Q3 2022 Vaxart Inc Earnings Call
Okay.
Greetings and welcome to the backs, our third quarter 2022 business update and financial results Conference call.
A question and answer session will follow management's opening remarks individual investors may submit written questions.
IR at <unk> Dot com.
As a reminder, this conference is being recorded.
I would now like to turn the webcast over to your host Randy.
<unk> senior Vice President of business operations.
Good afternoon, and welcome to today's call.
Joining us from <unk> are Andre Florio, Chief Executive Officer, Dr. Sean Tucker, founder and Chief Scientific Officer, and Dr. James Cummings, Chief Medical Officer.
Before we get started I would like to remind everyone that during this conference call backs are may make forward looking statements, including statements about the Companys financial results.
Financial guidance.
Its future business strategies and operations and its product development and regulatory progress.
Including statements about its ongoing or planned clinical trials.
Actual results could materially differ.
From those discussed in these forward looking statements.
Due to a number of important factors, including uncertainty inherent in the clinical development and regulatory process.
The extent and duration of the impact of the COVID-19 pandemic and other risks described in the risk factors section of <unk>.
<unk>. Most recently filed annual report on Form 10-K, and other periodic reports filed with the SEC backstop.
<unk> undertakes no obligation to update any forward looking statements. After this call.
I'll now turn the call over to Andre Florio.
Andre.
Thank you Ed and thank you to everyone for joining us today.
We're pleased to have this opportunity to review with you our third quarter progress and showcase the transformational potential.
The oral vaccine platform.
I'd like to start with a financial update that I believe is of interest to all investors.
In August of this year, our shareholders approved our proxy proposal that's authorized an increase in our authorized shares by 100 million to 250 million chips.
During the proxy voting process.
Many of our individual shareholders.
The testing this proposal would lead to an immediate and significant dilution.
I'd like to put that concern to us.
In the third quarter after passing disposal, we should only one 8 million shares.
Proving that as economies.
We will continue to be very prudent and opportunistic and issuing new shares.
So I would like to again, thank our shareholders for their support and tell them that their trust had not been misplaced.
Now let me tell you why we're very excited about the work that we're doing our best product and about the significant potential of the vector has both to make a big impact on how we fight infectious disease globally and to create significant shareholder value.
Since the beginning of the pandemic that has drawn a lot of attention to its COVID-19 program and for good reason.
And while the potential of our COVID-19 program remained significant even.
The general interest in COVID-19, ebbs and flows.
I'd like to talk to you about the bigger story here.
It's a true platform company.
That is much more than just its COVID-19 program and there are two major parts to this bigger studies.
One is our other leading clinical program norovirus each of delivery presents a huge opportunity for Baxter.
The other is the broadband promise that <unk> platform holds in transforming the vaccination paradigm globally.
While my colleagues will tell you more about the norovirus opportunity, let me illustrate this broader promise of our technology.
Recently.
I'd like to invite you to officially to attend the upcoming G 20 summit more specifically the <unk> portion of the <unk>.
So this week I'll go to Indonesia to discuss it with the world political ambitions leader that all of the <unk> platform could have in global pandemic preparedness in shaping the future of architectural healthcare.
Now small biotech companies do not usually get invited to the G 20.
However, that's that indeed, because of the transformation of potential profit technology.
Brazil is one of the summit main areas of focus this year.
How to model global healthcare architecture with had the world recover together recovered strongly which is one of the models of Dcs <unk>.
And the Indonesian government is just one of the governments that are interested in exploring the role our platform could have an improving pandemic preparedness for.
For this pandemic and future demand.
Now while I set up this development because I think they can help you paint the full picture of what is going on at <unk> and.
And because the very real interest in the transformational nature of our platform and our programs.
Our loyalty Susan I state the obvious.
While we are hopeful that this interest will translate into tangible support for vaccines.
There is of course, no guarantee that is will be the case.
So.
These all this interest justified.
We certainly believe so and I.
I'd like to review with you the promise of <unk> platform are stalled by the data that we have generated so far.
First using backpacks platform, we produce the only oral vaccine shown to be effective as a leading injectable in few months against that it stood up very pandemic virus.
This is a remarkable result.
Appeal that can be taken a little bit glass of water protected as well.
Commercial vaccine that need to be administered by injection.
And what makes these results even more interesting.
That would show that the oral appeal protected by working very differently than the injected.
That satisfaction August six to 10 times less anti body that is adjustable.
Yet the protected as well, presumably because it also activated mucosal immunity let.
Say it again.
<unk> vaccine produced up to 10 times less serum anti bodies that the injectable yeti protected as well.
This point is worth noting because.
In our legal centric world there is a tendency to assess all of the data using the same length, because thats used for injectables, namely.
Namely looking only at scale data.
Yet or getting the other arms of the immune system Gotcha mucosal immunity are also important contributors to protection.
Hey, Ken the data we have produced so far across our multiple programs suggest that our vaccine candidates also triggered a mucosal immunity and hour and that our vaccine platform has the potential to offer advantages over injectable vaccine.
Area.
Broad cross reactivity against area.
Reduction in viral transmission longer protection and then more.
More benign thought it might be.
Improvements on even one of these dimensions will be significant yet our data to date suggests our vaccine candidates may well have the potential to improve on all four.
But that Parker will review these data in more detail and you can now also find more on this.
Our new Investor deck, which is available on our website.
So for now I would just like to quickly provide some highlights.
But we think is very encouraging is that each of the four potential improvement.
Is supported not by just one but multiple data sets from across.
Our programs and trials.
Good morning.
Across the activity cross reactivity against Covidien and other Coronaviruses was shown in both our COVID-19 clinical trial, so in two of them.
The reduction in transmission or viral shedding was observed in flu and COVID-19 studies.
Durable protection or immune responses were seen in flu norovirus and COVID-19 trial.
And to date, the benign taller ability of the vaccine candidates, we have produced using our platform.
Supported by <unk> clinical trials with more than 500 subs.
Therefore, we believe that the full promise of our platform should be assessed by looking at the totality of the data we produce across our many programs rather than by focusing on any individual program.
And as I said.
That forms the promise is much more than the potential any single program no matter, how promising that program is.
In conclusion, let me synthesize why we're so excited about where the backside of this debate.
Truly transformational potential supported by growing data across programs.
Cost several financial resources.
Strong team and significant clinical Readouts in 2023.
These results include two human Challenge studies in 2023, one for norovirus and the other for COVID-19.
These catalysts are sitting.
Michigan, because challenge studies have efficacy end points, namely assessing whether vaccines can protect against infection, rather than just looking at immune responses.
And now I'll turn the call over to Dr. Shawn Parker to review our recent data in more detail then James Cummings, Dr. James Connex will discuss our clinical trial program Sean.
Thanks, Andre as you mentioned, we have several key differentiators of our vast platform, but let me try to provide some color around the data.
First our platform has shown the potential to provide potentially a broader immunogenicity and the injected alternatives. For example in the phase one study of our <unk> plus <unk> COVID-19 vaccine construct 46% in the subjects had a one five fold increase or better against Sars <unk> in the nasal Iga responses.
And all of these responses are highly cross reactive against all the coronavirus, we tested again, not just sorry Tobey too.
Really divergent coronavirus is the beta and the alpha families.
Further we observed that many of these study subjects had responses that were elevated for up to a year.
We have also shown substantial cross reactive T cell responses against <unk> in particular, we showed substantial CDA T cells, which are much harder to induce by adjuvant alone. So this is a very important point on the T cell side of things.
Let me tell you a little bit about our COVID-19 phase III study. This is the <unk> protein only study.
And then emphasize the point again about cross reactivity.
Coastal responses in vaccinated individuals where cross reacting to other cards can be too and the berries. For example, 50% of the subjects had a mucosal response to Wuhan.
In fact, 55% of those subjects had a Newcastle response to the more.
What I would say presence.
President circulated starting the omicron four five so effectively everyone that we induced in the Newcastle response against Wuhan also responded to the more.
Personal are the strains that are going on now.
Second let me tell you a key advantage another key advantage of our platform.
We believe that we will get longer duration of immunity and we believe it will be longer the injected vaccine.
As you may have read there've been reported issues with the durability of some of these injected vaccine, particularly with the COVID-19 mrna vaccine and the injected influenza vaccine. So here's some of the highlights of our data in our first phase one norovirus strong trial, we saw a rise in fecal Iga responses were durable for greater than six months.
And our flu challenge study. This is on the sponsored by BARDA are all vaccine had 39% protective against the efficacy against illness, and 47 protective efficacy against infection.
That we tested this by looking at infection 90 to 120 days after vaccination not the typical 30 days it what Alan said he is usually look at we looked at this a lot some longer time point.
Also as I mentioned earlier that COVID-19 phase one study <unk> plus and we showed in Asia Iga responses that remained elevated for over a year.
Lastly, in our norovirus elderly study. This is data that we released this summer showing Iga and IGT responses. These were still elevated even after 200 days.
Third point that differentiates our oral vaccine or pill vaccine platform has the potential to induce or reduce transmission. The proposed mechanism of <unk> and Newcastle Iga response, this hinders the virus spread to other individuals.
There is a substantial Newcastle IV a response to the notice this iga can hit you be shedding.
Respiratory pathogen essentially blocking the productive release of virus.
Here's some of the highlights of our data in our phase II Challenge study and analysis conducted by BARDA. There was an 80% chance of our oral vaccine significantly reduce viral influenza shedding better than an injected commercial influenza vaccine and this was in a head to head comparison.
And the COVID-19 study and a hamster study led by Duke University, our vaccine candidate delivered orally or intranasal aid limited airborne transmission of Sars Cov, two two unvaccinated animals animal that never seen vaccine.
And let me highlight this point again the opportunity to reduce transmission, we had a major advantage in the fight against COVID-19, because if you can get.
You can reduce the speed of the virus propagate the population fewer people will get infected at once and this will not stressed out hospital care and other critical resources devoted to care of the sick people and if you can reduce transmission enough below and are not to the virus will essentially burn out.
In study after study Baxter Baxter has built a compelling case for oral pill vaccine technology and for the vast potential benefit can deliver to society and to shareholders. We have the advantage of being further head at many of our U S competitors in the Newcastle space and we are committed to completing our mission to bring till vaccines for the world.
Furthermore, bypass bypassing the need for expensive cold chain storage hundreds of millions of people in developing countries, who cannot readily eggs access injectable could finally have access to lifesaving vaccines.
In all countries, where our vaccines receive approval the environmental impact and cost savings would be significant and then there was that last mile of vaccination in developed countries.
Clearly our mucosal vaccine talent technology holds great promise and we are committed to turning that promise in the vaccine that can address the important public health challenges and create value for our investors.
Now I'll turn over the call to James Cummings, Dr. James Cummings, who will view recent achievements next steps and upcoming milestones for our COVID-19 in norovirus vaccine programs James.
Hey, Thanks, Sean.
I'll begin with our COVID-19 clinical vaccine program.
Early September we reported top line data from part one of our phase II clinical study evaluating our S. Only COVID-19 vaccine candidates. The 201 study the.
The vaccine candidate evaluated in the 201 study was developed based on the viral spike protein of the original Wuhan strain of Sars Covid two.
The data from this study clearly show that this candidate was safe and well tolerated.
These safety findings are consistent with results from over 500 subjects, who participated in clinical studies of our tablet vaccine platform.
Notably few or no subjects in this 201 study reported any symptoms to the severity that were commonly reported in the clinical studies of the needle injected vaccines.
The secondary endpoint of the 201 study was the Immunogenicity of the S only vaccine construct.
Multiple assessments demonstrate that this candidate induces potent antibody and T cell responses and stimulates both serum.
And your coastal immunity.
In terms of next steps, we have several important near term milestones in our COVID-19 vaccine development program.
The most efficient pathway to meaningful data.
Our Covid vaccine program.
The Omicron Covid challenge currently being developed by HB, though in the United Kingdom.
Once they're challenged model has been validated we.
We will move forward with testing our most promising construct.
As a booster for those previously immunized with a needle based vaccine.
We look forward to having data on vaccine protective efficacy.
Impact on viral shedding.
And correlates of immunity.
That will help shape the studies following after that challenge.
I can tell you we are committed to developing the candidate with greatest likelihood of success.
<unk> III study.
Regarding the study in India.
That study was designed well over a year ago.
And much has changed in our understanding of Covid and the landscape of potential solutions.
While we continue to work with the Indian government and dialogue with potential partners with the best next steps for our product in India.
We look forward to the Covid challenge with H vivo in the UK to further refine our Covid program pathway.
In June we reported positive preliminary data from a phase one b trial of our norovirus vaccine candidate and subjects, aged 55 to 80 years, which showed stimulation of robust immune responses across all doses with a dose dependent.
<unk> production of Iga antibody secreting cells.
We're really excited about these findings because they demonstrate the power of our vaccine technology approach and because adults over the age of 65 years are especially vulnerable to norovirus infection with with seven 5% of this population infected every year.
The data generated so far suggest that our norovirus vaccine has the potential to provide protection against norovirus across a very wide age range.
Building on the data generated to date, we expect to initiate a phase two trial of our bivalent norovirus vaccine.
This vaccine includes two norovirus proteins potentially stimulated even more robust immune responses.
Then we have seen with our monovalent candidate.
We have a pre specified futility analysis of our study reporting shortly and if that is positive. We expect to report preliminary data from our ongoing phase III Norovirus Challenge study in late first quarter or early second quarter of 2023.
We're really very excited about the prospects and the upcoming milestones of our clinical trials and continue to demonstrate the transformative potential of our oral vaccine platform.
And now I'll turn the call back to Andre for some closing remarks.
Thank you James and also thank you Sean for reviewing our.
Clinical data and our progress in outlining some of the.
Key milestones are ahead for us.
And now before we move to the Q&A session let.
Let me say, a few words about our cash position and upcoming milestones.
As we announced in our press release as of September 30.
2022, we had cash and cash equivalents of $114 8 million.
In closing I am pleased that we are on track to report key updates on our promising pipeline programs drove the remainder of this year and during 2023.
Our team is motivated passionate and excited and lot of share and I share that excitement.
We build on our momentum and advanced our oral pill vaccine platform.
Looking ahead, we are focused on enabling a wholly new approach to vaccination that truly has the potential to be the solution to the challenges of low longstanding and emerging infectious diseases and to overcome historic inequities and vaccine accident.
Thanks to everyone, who has joined us.
For today's call and especially authority investors, who continue to support our mission.
We will now begin the Q&A portion of our call.
Operator.
Thank you the floor is now open for questions. If you have a question. Please press star one on your telephone keypad at this time, please hold while we poll for questions.
Okay.
Our first question comes from.
Duncan with Cantor Fitzgerald. Please state your question.
Hi, This is Pete stavropoulos on for Charles I would like to say congratulations on all the progress made.
Nice quarter.
So I have a question on the Norovirus program I know that you are planning to initiate the phase III. The bivalent vaccine candidate in <unk> or <unk> 23.
Can you speculate on the size and duration of the study and will you be looking at Immunogenicity.
And an efficacy or one or the other and how will it differ from the other studies that you conducted in.
Norovirus.
Sean. Thank you for the question, Sean you want to take this.
Yes, again, Pete Thanks for the question. So the study is Immunogenicity study, it's approximately 600 subjects I believe the plan it will be at rolling to two to one two different dose levels and placebo.
Again, as I mentioned before it'll be immunogenicity.
The readout would be some time.
In the middle of next year.
I don't think there is efficacy endpoints described but again, we hope that this stack. This study will basically sort of the basis.
Or going.
Going forward to the FDA with an end of phase II meeting.
Alright, thanks, and in terms of the challenge of the normal.
Norovirus Challenge study.
Can you sort of make a comment.
Sort of how enrollment is proceeding and are you on track too.
No we're not.
<unk> 25.
Yes.
Enrolling.
A reasonable rate our expectation is that we will see data Q1 of <unk>.
Next year.
Alright, great. Yeah. So we said we said we are still on track with previous guidance, which is to report data end of Q1 early Q2 next year.
And actually back to the phase II, we were just discussing.
What are the gating factors and have you actually manufactured the required materials for the study.
I don't know that there are any gating factors.
We again, we announced that we are on track with what.
Plans to start back.
End of Q4 Q1 of this year.
Okay. Thanks.
One question on Covid program.
There is data out there and also authorizations for army corn specific boosters.
Really different vaccine platforms, how does this sort of impact your thoughts on your program and sort of which candidates youre going to bring forward.
Yes, I mean, obviously there is definitely some people that are done with omicron specific I think the data out there is a little mixed in terms of the other is important.
Again, what we said we were going to do is we're going to take a look at our data from our phase one and phase two S. Only as well as looking at some of these new construct and making some decisions about how to go forward.
For the next steps.
One of the things I did want to point out is that we did see some strong cross reactive responses against omicron in that phase II study both in theory mucosa, and certainly that is weighing on us a little bit from the standpoint of making decision on how the next.
Next steps and looking at efficacy in that Omicron challenge, obviously that would be a great first step or next step for the program is to test our vaccine and show not only that figure could be protective.
And a challenge model, but whether they correlate to protection from the Newcastle vaccine.
Alright, thank you.
Okay.
If I can add something here so.
I think.
We all know that the shortcomings of the injectable vaccine is backward looking if you want so they.
Our design about four eight.
Variant of the past right.
And I think Thats one of the reasons why you see uptake in vaccination with the Nuomi Corona or bivalent vaccines being so low because.
I, especially late here, but we're really not sure. How these are going to protect against the emerging variants and.
Was it because of immunity, we have the opportunity here to demonstrate cross reactivity and to potentially demonstrate the fact that you don't need to change vaccines.
<unk> change and therefore, you get off this hamster wheel why do you keep it running.
A pandemic evolves faster than we can vaccinate.
Got you. Thank you for the added color and definitely looking forward to some data from the human Challenge studies.
Our next question comes from.
Mack <unk> with B Riley Securities. Please state your question.
Hi, Good afternoon team. This is Tahoe Academy on for Mike asking a few questions here I really appreciate the comprehensive update.
Maybe piggybacking off the most recent question now that we're seeing five representing less than 40% of cases or so in Q1 getting more prevalent just curious how far along you and your partners are with identifying virus dose used for the challenge study.
Hi, Dante Hi, this is.
This is <unk>.
Hey, Sean.
Yes, I don't.
Yes.
Right now what we're doing is we're certainly looking at a <unk> five from the standpoint of Omicron Challenge. We think that's borne informative in terms of like really testing the vaccine.
Youre right <unk> is now coming up and it could be very important and again, what we will do is we will start to monitor our candidates and how their immune responses differ from peak.
From that from those variants as well one thing to note and Andre brought this up earlier is that we have noticed that our vaccine seems to do actually quite well against the omicron NBA for five and I expect that will happen that'll look okay as well again.
And the <unk> as well.
Excellent. Thank you and then.
Pertained to the Norovirus program and the challenge study that we're going to expect to see early next year.
Can you give us some color on what the threshold for a highly attractive profile might look like maybe putting in context, but we've seen some of your peers do in the field.
Sure I'll take this question.
One of the things that of course is that when we're using the talent strategy using really really high doses of virus and so the expectation is that it.
Will the challenged results will be something in terms of percent efficacy will be on the what I would call low end it would be something on the order of 40% to 50%, having said that we have no it could be higher as well.
And again.
The one challenge study Thats been published it was successful.
Leukocyte <unk>, one that was done several years ago and I believe the efficacy on that vaccine was about 40, some odd percent. So.
<unk> challenged models are great from the standpoint of understanding can your vaccine to protective and what are the correlates.
You are using a quite a large dose as part of that process.
Great. Thank you I really appreciate it.
Yes, yes, that's great. Thank you very much and congratulations on all the progress I. Appreciate you, taking our questions and best of luck Andre at the G 20.
Thank you so much.
Yes.
Our next question comes from.
He handles fin Ryan with Brookline capital. Please state your question.
Hi, Thank you for taking my question.
So as you May know Oculus Holdings recently announced a collaboration with CSL CSL secured us a global vaccine company.
To develop and commercialize self amplifying mrna vaccines.
That regard I was just wondering do you think it highlights and Kristin emerging Watson technologies among global companies I mean, what are your thoughts on it.
Yes. Thank you. Thank you for the question. So this is Andre.
Sure.
I think it definitely does and if you. If you saw that agreement it was about Colgate that solid influenza and was.
What I will call.
Pandemic preparedness oriented and I think pandemic preparedness is a theme that we see emerge.
Quite quite a lot recently at least in our conversations with various.
Government and governmental bodies, so I think the.
The interest from investors and Colgate, specifically may whether flow, but but if you talk to healthcare bodies in government I think that I think and the increased awareness that we need to be better prepared.
Against.
Potentially you said a wave of coffee, but specifically or more importantly, I guess future Pandemics and there is a growing realization that fighting this pandemic with just the current generation injectable vaccine is not the best way to go and therefore, we need newer technologies. So I don't know if.
This.
Ask your question.
Yes. It does thank you very much.
Well I would add I would add that we hope.
And then our clients will see that.
This will also translate in.
Increased interest from large biopharma in the sector.
Great. Thank you Andy.
At this time there are no more questions.
In the Q.
I will now turn the call to Brad <unk> Senior Vice President of business operations to moderate the impact of the questions portion of the call.
Thank you very much.
We'll turn to questions from individual investors and while we have a number of these questions. Some I think have been covered in the analyst questions that came in.
I don't know if we want.
Push out or expand Andrzej. This first one was what's your approach to potential partnerships for either COVID-19, or norovirus programs. I think you covered a little bit of that but do you want to expand on that answer I just gave.
Well, maybe just a little bit.
I'm going to state the obvious which is that what we had said in the past that.
Can you we are always interested in looking for the best ways to.
Further the progress of our <unk>.
<unk> platform in multiple programs.
So and to maximize shareholder value. So we continue to be.
Open to exploring partnerships, whether here in the U S or abroad.
Thank you Sean this last one is going to be for you.
The question is where do you see <unk> COVID-19 candidates fitting into the Nextgen vaccine landscape Sean Please.
Sure well, we certainly see our <unk> based vaccine as a standalone vaccine for those who haven't been immunized, whether because the needle fair because of large logistics requirements, such as cold chain medical supply personnel.
Obviously in the U S and other countries a lot of people have already been vaccinated and or infected. So it's really going to be a booster and a lot of populations. We see it as complementary other vaccines now we certainly have tested ours of the booster with mrna is and we know we can make me coastal immune responses and of course, we think that.
It might be better from the standpoint of creating and be coastal across various protection.
And potentially reduce transmission.
Excellent. Thank you Sean and that's actually the next one will be for you as well.
What other infectious diseases would be good candidates for the best platform in the future and the second part of this and are you looking at any specific target indications Sean.
Sure. Thanks, well, obviously I think we have.
In the past and looking at targets that are essentially borrow base, but certainly I think that any vaccine that can benefit from mucosal response could be a really good.
Indication to go after our current vaccine pipeline, obviously includes COVID-19, respiratory pathogen norovirus and tariff influenza respiratory RSV.
Which would be respiratory as well as HPV, which would be something that we can start with something thats cervical dysplasia. So again theres lots of different targets, we can go for and.
And because the platform is very easy to use American discussed a lot of new ones today.
Great. Thanks, Sean.
Great. Thank you covered this next little a little bit during your opening remarks, but the question is what's your current cash runway if you could expand on that a little bit.
Yeah.
Sure sure Bryan so.
Okay.
We said that we ended the third quarter with $114 8 million.
Which means that we have sufficient financial resources on hand.
To continue to execute.
Our planned into the second half or.
2023.
And that includes aggressively progressing our two lead clinical programs, which is not all Harris and COVID-19, but I want to put this in in.
In more perspective, so I'll make two additional points.
We believe that we have compelling catalysts in the near to medium term that may create new or more compelling funding opportunities for us.
And the second is that there are levers that we could pull to extend this runway significantly.
If we have a thing that would be appropriate.
Okay.
Excellent.
Sure.
I guess when you kind of have the next question a little bit what are the plans for funding the company and so maybe just expand that last.
A little bit I guess.
Okay.
Well so.
We continue to pursue various funding sources available to us.
I mentioned in my opening remarks that we continue to be engaged with the government around the world, We think that our platform.
Present.
Very compelling potential advantages to current technology. So we remain hopeful that.
These conversations may at some point would result in.
Funding, but again there is no guarantee of course.
When also.
Pursuing a strategic.
Strategic partnership discussions.
And as we've done in the past Opportunistically.
Accessing capital markets.
Great. Thanks, so much.
So there is a lot of questions coming in for COVID-19 will find bundle some of them together, so that were not repeated and so I'm not sure Sean.
So on the first one I'm going to.
Over to you and it says please provide update on timing for the COVID-19 vaccine construct what's the decision date and providing the rationale for any changes from previous expectations.
Hi, Paul.
The COVID-19 vaccine construct well based on our data from the phase one as an end of phase II as the only in the newer concepts. We're working on the research we plan to move forward to select our construct for our planned HTML covered challenge in the second half of 2023, obviously the strong cross reactive response against Omicron, we saw from our phase III <unk>.
While in the Wuhan and this is with the Wuhan is a strong candidate for the challenge study and of course, we think this could allow us to speed up our development pathway.
Excellent. Thank you and sort of a follow on question really is just the same question about.
We'll get this one over to you what's what's the timing for the challenge study commencement I think you hit on it already but are coming is also hit on it but if you could just reiterate what our timing is for the challenge study for Covid.
Are we on track for second half of 2023.
Sure. Thank you, Brian So we had said that.
We're going to initiate this trial in the second half of 2023.
We are on track for that and we are also looking at ways that would make that would make it possible for us to start that trial sooner.
And so once we identify.
Those those path, we'll obviously make that announcement.
Great. Okay. So on the first one's for you.
The phase Iia trial for covered the question is will you be releasing additional insights from the phase Iia trial beyond topline data that you announced in September .
<unk> Sean.
Yeah.
Second we will have new site insights to present at the World vaccine Congress in San Diego coming up at the end of the month and obviously, we're continuing to analyze the data.
Gain.
And new things coming up.
There is something interesting you released we will release it when it's available.
Okay. Thank you.
Andre. This next one is going to come to you and it's back to the Covid Challenge study again, so if Covid challenge study results are positive do you see an accelerated path for vaccine approval.
Well so.
A bit of.
Challenging question, because it really depends on our results from that the challenge study.
And it also depends on the state of the pandemic.
At that time so.
We are in touch with several regulatory authorities both here in the states with the FDA and outside of the U S to look at.
Global application of our platform against COVID-19.
So.
As we've seen during this pandemic these regulatory authorities.
Can make different decisions, which are based not only on the strength of the data, but also on how cute there are unmet needs. So.
It really is really a challenging question to ask now, but we remain very confident that the benefits of our needle free pill based vaccine.
That can provide many of the advantages.
We talked about you know durable protection.
And I guess.
Various very uncertain, so on and so forth, but remains a compelling proposition.
Thank you so much I've got a couple of construct questions. Sean This is going to come your way. The first one you've kind of hit a little bit I will ask the question and get you to expand on your initial answer my question is what factors will inform the construct you've taken to the challenge study in a potential phase III trial.
Yes, I think right now I think the most important thing from the standpoint of deciding what to pay for it. The challenge study is how our bicoastal Iga and neutralizing antibody do against Amazon as well as our ability to universities TBA CDA T cell response.
The data from the trials, where we are boosting subjects. They got an mrna vaccine might provide additional guidance immune profile since when we go to challenge people are already going to have add a vaccine.
An excellent and the next question is really about <unk> is kind of somewhat similar to <unk>.
One of our analysts questions when they ask it and then you can maybe expand on the other answer that you gave the question is if the current construct is cross reactive why are you starting over with omicron construct.
Amazon be obsolete by the time Youre construct is complete Sean.
Yeah, I think we've talked about this a little bit maybe I'll be a little tighter the language and obviously we are confident in the cross reactive responses of our existing contracts I mean, we certainly have proven that bolt with phase one in the phase II.
Never I mean to be scientifically rigorous we wanted to look at the on the current construct.
Credit to compare them to the other ones at least pre clinically because again, we want to make sure that.
Things are good and we have the best.
Vaccines going forward.
Whether on the product will be obsolete well things change, but I.
I still think the omicron family seems to be the one that's popping up more commonly these days so.
Great. Thank you and then the next question Andreas pump.
<unk> over to you and you've already mentioned that youre going to the June 'twenty, but I'll, let you expand on this.
<unk> do you believe that <unk> will have a place at the table in terms of key government officials recognizing the need for oral vaccines Andre please.
Thank you thank you Brian .
I hope that I provided.
Also which is obviously, yes.
So we see that there is interest at least in discussing how our technology, which is fairly unique Ken help in this pandemic in future one.
So.
There are several.
Countries with which we have discussions we continue to have discussions and as I said the focus not only on COVID-19, but beyond COVID-19 on.
Pandemic preparedness.
So we remain excited.
To have these discussions we actually feel.
Honored to have.
Some of them like the invitation I mentioned to the B 20.
And we do hope that eventually we will receive some tangible support but.
As I mentioned.
In my opening remarks, you can never be sure that these conversations will.
Got it into something tangible Hollywood again, what I can tell you right now is that our message about the potential of our platform.
As with many.
Excellent. Thank you alright, Sean this was going to come back over to you and ask the question that we get asked quite often here actually and the question is.
<unk> oral tablet vaccine differentiated from the intranasal vaccine candidates.
Yes. This is a very good question. So obviously there has never been a head to head comparison between an intranasal and oral vaccine candidate leased for COVID-19, or any or for anything as Brian from everything I can see.
The limited published intranasal vaccine data that we've seen has not really been that encouraging to say the least the immune.
Immune responses just haven't been that potent from what I can tell there is an aerosol vaccine or keep in mind. This is not this is inhaled through an apparatus not sprayed into the note. It was approved in China and there actually are some publications out there in fact quite a few.
I think our data actually compares quite favorably with the caveat of course it is not.
The head comparison done.
I think particularly on the Omicron response in the serum mucosa, I think our data looks actually more compelling.
Lastly, why is true in India, and Russia have moved forward with intranasal vaccines.
There is there is no data really published yet and I don't and I really don't know what the basis for approval was.
I think that means it's kind of I'm, a little cautious and I think we should all be a little cautionary about the fact that the data hasnt been published yet these things are approved.
Great excellent. Thank you so much okay theres a couple of sort of duplicate questions. In here. One is what's the prospect for U S or international government funding under I think you've handled that.
Just recently the next one was what's your thoughts on a regulatory pathway I.
I don't know if you want to add any more on what you've.
Already previously mentioned.
If not we can move on now.
No.
Turning to address that I don't know if I can do any better.
Again, it's hard to speculate.
Decisions could be different in various cities around the world.
And they depend on how well we're going about doing this challenge study.
While the perceived a mandate will be at the time, but we continue to be encouraged by the fact that we have a very differentiated platform here and the data so far continues to be very encouraging.
Thank you I think we've got time for a couple more questions. Here. This one is coming in about the workshop, Sean So it's going to come to you with you just in the midst of doing.
I noted the November 7th or eighth workshop on mucosal vaccine for Covid. The Dr. Tucker speaking as it seems like a fantastic forum to educate the scientific community and pandemic preparedness community on the benefits of <unk> candidates.
Create some buzz for the company it would seem natural to alert investors on Wall Street, but I haven't seen a press release.
Help me understand the importance of this event. Please if you could comment about the meaning just wrapping up.
Sure I think you're referring to the NIH mucosal vaccine for star Kobe to tie to the gas <unk> opportunities.
It's a workshop not really got public content and but let me tell you why it was important.
The good news is our vaccine had strong enough human data.
The invitation event.
He was able to you to discuss our orally administered vaccine could provoke a protective response against the respiratory pathogen and talk about our Blue study and also talk about the very potent nasal Iga response, we get and I think it was well received and.
Always happy to be invited to participate there was a big step forward for us I think to get our IND.
Information out there.
Fantastic and Theres, a couple of last norovirus questions and I'm going to ask Sean I just wanted to start for you I think we've already mentioned this but please if you could elaborate just a little bit. So the question is would we see any preliminary data on the normal challenge study prior to Q1 2023.
This study is a double blind placebo controlled study to prevent bias and the data, we arent going to them.
Unblinded.
Until it's ready to be unblinded, and then at that point, we will be able to see how well our vaccine didn't really understand the data.
Excellent and then the last question on Norovirus, what support potential next steps for this program following the challenge study.
Sure and we've already announced plans to move forward the bi valent studying and again just to make sure everybody knows that cover both the <unk>, one and <unk> four strains in norovirus, which are responsible for the majority of disease in adults for dose confirmation and the study is expected to begin late this year or early next year. So.
And this is a major step forward from our standpoint the company just before we go to the end of phase II meeting with the FDA.
Great. Thank you so much so that's the end of our Q&A and this concludes today's call I want to thank all the participants on today's call very much for their time.
In listening to back start story. Thank you bye bye.
Thank you.
[music].