Q4 2020 Vaxart Inc Earnings Call
[music].
Greetings and welcome to the <unk> fiscal year, 'twenty, and 'twenty corporate update conference call and webinar.
At this time all participants are in a listen only mode. A question and answer session will follow the formal presentation.
If anyone should require operator assistance during the conference. Please press star zero on your telephone keypad.
As a reminder of this conference is being recorded I would now like to turn the conference over to your host Mr. David Holmes of lifestyle Advisors. Please go ahead Sir.
Thank you Hector.
Good afternoon, and welcome to the Backstop of corporate update conference call with me today are Andreas for Ya Baxter, Chief Executive Officer, and Shaun Tucker the company's scientific officer.
During the course of the conference call, we won't be making forward looking statements regarding the future events and the future performance of the company.
These forward looking statements may be accompanied by such words as should believe could potential well expected plan and other words.
In terms of similar meaning.
Examples of such statements include but are not limited to statements relating to our ability to develop and commercialize our product candidates and clinical results and trial data are.
Our expectations with respect to the important advantages, we believe our oral vaccine platform and offer over and injectable alternatives ex.
Expectations regarding our ability to develop effective vaccines against new and emerging.
Marion strains.
<unk> role of mucosal immunity and blocking transmission of COVID-19, and our expectations with respect to the effectiveness of our product candidates, including our potential role and mitigating the impact of COVID-19.
All of these statements are based on the beliefs and expectations of management as of today. These statements involve certain assumptions of risks and uncertainties and could cause actual results to differ materially.
And assume no obligation to revise or update forward looking statements, whether as a result of new information future events or otherwise investors should read carefully the risks and uncertainties prescribed and the safe Harbor section of our website as well as the risk factors included and the company's most recent quarterly and annual filings.
With the U S Securities and Exchange Commission.
Following <unk> prepared remarks, there will be a question and answer session and a replay will be posted on the investors section of the company's website.
At this time I would like to turn the call over to Andre Florida.
Please go ahead.
Thank you David and good afternoon, everyone and thank you for joining us.
I'm excited to provide and update on our clinical programs and outline some of all of the priorities for the coming year.
We start the the air without actually at all of that we started at the last year, where the peer reviewed publication and the last night I T. He should and can you sort of throw in the phase two clinical trial of the pandemic flu vaccine trial that was sponsored by BARDA.
And the flow Challenge study, we showed up all of the oral tablet the vaccine protected against flow as long as the leading the injectable of flu vaccine fluzone.
Importantly, all of all of the tablet flu vaccine induced produced much lower levels of total.
The neutralizing antibodies and flows though less than 110th of asthma.
Bottle of south of protecting this is a very important finding.
And that's in the context of COVID-19 settled and yes, I don't like the anti bodies.
The key metric for the injectable COVID-19 vaccine.
So it is very important to recognize that for our oral tablet vaccine settle neutralizing anti bodies out of not on the appropriate proxy for the efficacy.
The protection of all the oral vaccine in the flow Challenge study was driven in part by B cells that the rest of the mice H I G class and so.
For the postal Hai titers for all of the Injectables true vaccine.
These results provide the important evidence that the all of the vaccine here's what it thinks the little bits of the mechanism of action than injectable vaccine.
In fact, all the oral vaccine generated of blow the adaptive immune response, including of course, the T cells and local Iga, so effectively protects all of the influenza.
For the last year and the beginning of the COVID-19 pandemic. Our team had the foresight to design the vaccine that incorporates both the spike S and nuclear parts of seed and vital cluster.
This approach was based on all of the expectation that Corona virus, what's the likely to mutate and it's gone and you asking you for the the Dania.
The and protein is more conserved.
Less prone to mutation and those sort of a great target for the potent T cell responses.
And the recent studies suggest the thought of getting the and Porky main just blow the protection from the new variants of sort of Covid too.
Therefore, we are very excited about moving towards face to the COVID-19 vaccine candidate that could be transformational.
And all of the tablet that first of all of a very different mechanism and wish the proved to be of very available globally against the fight against the.
And the fight trial data in the <unk>.
The guest the quote on the environment.
We believe our COVID-19 vaccine construct has several important advantages.
One of the triggering of mucosal immunity. The the first line of defense against that of borne pathogens such as Scott on the virus to the E.
Hum.
And three of the simplicity and lower of cost of distribution of a room temperature stable P O.
And recently, we have seen the emergence of new Sars Covid two strains.
And that's the way some of the leading the injectable vaccine so for the reduced the protection.
And the same time.
And it's become clear that the mass vaccination of the buy neither will take a long time and.
And then you change the name of emerge faster than we can vaccinate people. Therefore, a better solution is needed given that the COVID-19 may be a challenge for the years to come.
Our strategy for the packaging this global challenge for them.
Employee of Multivalent portfolio approach looking to improve on many aspects of the first generation and injectable vaccines, including convenience and speed of administration breadth and depth of protection and ease of of course of the submission.
Okay.
This involves advancing our S and vaccine candidate into phase III, while in parallel developing as the only vaccine construct.
We believe that with our COVID-19 vaccine portfolio that side of it will have multiple path for all of it depending on geography.
The developed world and you'll both single dose of previously vaccinated all of the affected with the.
Potential of comfort and cross the barrier protection and.
And the developing world the Novo vaccination with the much more of practical solution and cold chain dependent injectable.
Yeah.
Based on the fundamental underpinnings of our auto delivery platform, we have all sort of start up at all of the Norovirus program and.
And so quickly and mine there the United States ease of approximately 20 million little virus cases every year.
Has the economic impact is felt mainly by children and under the age of five sort of anybody over the age of 65.
The recently published has the Colombia, they thought from the American Journal of preventive medicine for the cost of the.
But of course with over $10 billion annually.
Based on these data and instead of a left and that's we believe there is an annual 10 billion dollar plus opportunity for abnormal virus vaccine in the U S alone.
We are currently and the clinics with dish norovirus vaccine administered and will start of doses.
Patients who participated in our audio to metal via the stays on bi valent the study.
So they thought were generated here should give us some indication of the duration of protection provided by of our vaccine and that's one of the magnitude of response that the generated by the Bushnell.
In addition, the theater, we have 12 additional studies plan. The first we'll evaluate all of the metal via the vaccine and people over the age of 65.
And the second and there will be of challenge study that will provide us with the efficacy data in this disease model.
Okay.
I'll conclude by reminding everyone that to date we.
We have nearly 500 subject.
And the vaccines and based on our order platform.
The other thing in clinical trials.
Trials sort of getting several different virus.
And now to provide some additional scientific background I would like to pass the microphone to Shaun to discuss all of the COVID-19 of tableau vaccine phase one that he felt shop.
Thanks Andre.
And this was the phase one study the primary objective was determined the safety of the Xa koby to dash one our oral COVID-19 vaccine delivered by tablet overall the vaccine was appeared to be well tolerated 60 per cent of subjects reported no symptoms and the seven days post vaccination and among those 40 per cent of you did experience symptoms of the majority of the only mild center.
And these resolved without the need for medical treatment no subjects discontinued the study due of solicited adverse event and to date there've been no serious adverse events reported.
The secondary objectives of this study with the determine the immunogenicity of the vaccine overall immune responses against Sars Covid two were observed and approximately 85 per cent of the subjects.
We are very encouraged by the substantial T cell responses, we saw as the result of the tablet vaccine and I'm delighted the state that these results of the best we've ever seen and the study the cytotoxic T cells responses at day, eight and a high percentage of cells that made gamma interferon TNF Alpha and O C. D. One of the Peter one of the seven eight and response of stimulation with the ASP.
Protein with substantial increases compared to the first day of the study.
Potent T cell responses may offer protection against severe COVID-19 illness cross multiple variants.
B cell plasma and black which of the immune cells involved and antibody production also increased and the subjects posting the innovation. There was also upregulation of the mucosal homing receptor and surface Iga and those b cells and a dose dependent manner.
While no neutralizing antibodies responses were observed and the serum of subjects preliminary analysis showed the increases and Iga responses. The escrow T receptor binding domain and are the expert and protein could be found and the majority of the subjects.
As a reminder is the class of antibody the plays a crucial role of mucosal immunity. The first line of defense against respiratory pathogens.
These iga antibodies specific Iga antibodies were detected and several different compartments includes the nasal and saliva sample.
Given the dose dependent manner in which the b cells of interest for activated future studies of this candidate will focus on dose ranging and boosting to increase the mucosal responses the Sars COVID-19 two.
In 2019, we anticipate salaried and several studies, which were highlighted by Andre before for COVID-19, we are going to perform the phase two study part eight.
Immunogenicity and dose ranging part b efficacy and a boosting studied previously vaccinated and in fact and subjects.
For Norovirus, we are currently in the phase one b trial for booster vaccinations at 12 months or longer post first dose and we are planning dose ranging phase one study and the elderly 65 years of age and older as well as performing a challenge Norovirus Challenge study.
We look forward to advancing multiple studies throughout the year and delivering both clinical data and publications to support a proprietary oral vaccine platform technology. We expect these data throughout the year to provide the medical community and investors with the great opportunity for this novel and groundbreaking approach.
With that I will now ask the operator to open up for questions.
Thank you at this time, we'll be conducting a question and answer session. If you'd like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate your line is and the question queue. You May Press Star two if you would like to remove your question from the queue for participants using speaker equipment and maybe.
Necessary to pick up of your handset before pressing the star keys, one moment, please while we poll for questions.
Your first question comes from the line of my ankle my tiny with B Riley Securities. Please proceed with your question.
And steam for taking my questions and appreciate the update so maybe just picking on the last the topic that Jon you talked about around the around the study design and can you give us a little bit more color on.
And the number of patients the timelines and and and maybe also in the context of the recent FDA guidance document that came out last week, how and how how do you sort of Ah accommodate for the focus there being on neutralizing antibodies.
Yeah.
Hello, Sorry can you hear me now so yeah, let me, yes, and so thank you yeah, sorry, Yeah. Let me answer that question. So the first start of <unk>.
So the for part a is the dose ranging study, where they're gonna be three different dose levels and priming and boosting and all three levels of the ends of 16, but there's also it's broken out into elderly and young people to sort of get a good mix and that guideline guidance, we'll basically be able to provide us insights into how did the.
Go forward with a efficacy study and do and take the proper dose and dosing regimen and into a phase III efficacy study, which we plan to run the outside the U S and placebo controlled trial of.
And I believe the and for that study where approximately of total Andrew Baum of 900 and obviously.
You know with the recent guidance it did come out with the is the F. D. A in terms of using potentially surrogate we'd have to reevaluate that and certainly you know from this candidate the VX eight koby to one if its the T cell approach well, we wouldn't be able to use a surrogate from the standpoint of getting a proofing.
Essentially efficacy, we would still have to do of death, because the study and and prove that the vaccine can prevent something such as severe illness and hospitalization.
And the my this is this is Andre I just wanted to add to that that all of our conversations with the regulators indicated.
The indicated that there are plenty of one of the thought of vaccines and because of the vaccine and they indicate the flexibility in working with us to find the path for approval.
So we don't expect the same kind of metrics and proxies that are being developed for it.
Vaccines to to apply to us necessarily.
Actually that that brings me to the second question that I had around you know, yes, youre your T cell responses.
Comparably superior to what we have seen from other than you know the.
The recent nature of paper from.
Of Sterling and the there's a lot of you know in the greater coming out of highlighting the importance of Iga and also maybe you know T cell comparison has sort of started to come out against other peers, but can you comment on how your idea of the sponsors are looking like now relative to other.
More of like more of the intramuscular vaccines. The do you have any thoughts on that.
So just the you know it was a highlight and I would say that our Iga responses in terms of and we've compared in different indications head to head of our you know the coastal approach definitely produces much more mucosal Iga then the intramuscular approach I mean, that's pretty clear I mean, all of it and in the study we have not and of course done and head to head and <unk>.
Parison between all of our response of our approach versus and and injected vaccine, but I could I would say that you know as far as I know, we're the first vaccine company to report getting mucosal Iga of significance. So I mean as far as I know, that's where we're at.
Okay and.
And my final question was on unknown of wireless do you have any plans to do that.
The address since that is also a.
A big part of our you know the population that the school is due at the end and also what does that mean the read through because the pediatric and Covid is also very bad mood.
Yeah, I think right now the Oh, sorry go ahead.
No you you think it's Sean.
So, yes, we will be moving into the pediatric space and norovirus I would expect this to happen in a number of years rather than this year. So I don't think it will really overlap well, we hope it won't overlap with Covid too much of the key thing for US is that while right now all of our vaccines of.
And the Liberty and tablets, which are really easy to swallow for someone who was 12 and older. It becomes it's not you know of format that will be allow a small infant to basically take it up of child and so we are developing other formulations to a yellow to allow it to essentially be swallowed into sort of of swore slurry with the with the.
Buffer. So we were working on that but we will be moving into the pediatric space on norovirus.
Okay understood and and just last question and then do you expect a coronavirus vaccine to be a similar boost the Brian and boost of the one months of all.
Are you just doing though you have to run the study you're not sure yet.
Well, obviously you know the the answer is different with people that have been quietly infected or people that had been privately immunized and it would be with people that are naive we aren't doing this dose ranging study of course with people that are naive. So we understand more about the kinetics, but you.
You might expect that you know for.
A lot of the western.
And our World countries, you know a lot of people are already be immunized, you know within a year and half the people look at this in terms of of one day of sort of regimen on a boost.
Got it the 10, so much for taking my questions.
And then my and just to elaborate a little bit on that I think we what we want to do is to.
Develop a portfolio approach that cannot Como day, the sort of needs in different geographies and also keep.
Keep pace with the evolution of the virus right, so, whereas last year the challenge of us to develop any vaccine and I guess one strain.
And the challenges is now becoming developing vaccines that can offer a broad protection against.
Various variants of the president now of solar future ones.
So that's where we think that.
Vaccines, the target S M and perhaps in the in the combination with vaccines and that the only thought against asks for the video strength.
Play at all.
Yeah that makes a lot of sense, thanks, Andrew for that industry.
Yeah.
As a reminder, if you'd like to ask a question. Please press star one on your telephone keypad as a reminder, if you'd like to ask a question. Please press star one on your telephone keypad one moment, please while we poll for questions.
Your next question comes from the line of Vernon Bernardino with H C. Wainwright. Please proceed with your question.
Thank you hi, guys.
And Sean.
Thanks for the additional details as far as the update on the program with the Covid vaccine or concern.
So basically.
Basically as the.
All of my questions, but one thing that perhaps we haven't talked about and the while I was wondering if you could provide an update and that is is there anything going on with your collaboration with Johnson <unk> Johnson and Johnson. Thank you.
Yeah.
So that's.
And that collaboration.
Is it still ongoing and as you can appreciate the both off and J&J has been extremely focused and busy with our irrespective of COVID-19 programs.
And what studies are something to announce that's part of the next steps.
With all the food programs will one and make some public announcement.
Have you had any discussion with them as far as collaborating on the oral tablet the COVID-19 vaccine development.
Okay.
Nothing of substance that would the over the half to wood.
And you know announced publicly for the Mt.
Okay and the one again.
And maybe we see our results from the the ongoing Covid vaccine trial.
So the only thing we said was that we're looking to start the phase II trial in the Q2 and as we get closer to for that will elaborate on the panel of last following that.
Okay.
Thank you and look forward to the next a progress report.
Yeah.
Thank you so much.
Your next question comes from the line of shoe Pendu Centroid with Brookline. Please proceed with your question.
Hi.
Hi, I'm to Bindle on behalf of Kumar from Brooklyn, I really appreciate the business update. Thank you I had a couple of questions one was.
So for Q2 in terms of enrollment of patients.
For the Covid vaccine. So you do see any challenges, especially for older patients now that we have and <unk>.
Vaccines up there.
Do you see that could be a problem one of them.
Hi, This is Andreas thank you for the question.
It is hard to predict it's hard to predict the future, but we think that given the attractiveness of on all of COVID-19 vaccine.
Given the relatively small number of patients that we have made for the dose ranging study and given that we still expect a significant share of the U S population to not have been vaccinated.
And at this point, we don't see at all of them at this being a significant issue, but we'll we'll update the necessary as we progress.
Got it thank you and I wouldn't I would I'm, sorry, I would I would add that I think conducting of placebo controlled trial.
And the U S and and broadly speaking the developed world may be a challenge because it's placebo control of them, there and a lot of but in the dose ranging study and you know all.
All of the subjects that are kind of beyond active drugs. So that you know minimizing minimises the charge.
Right right and.
In terms of the product need of coffee school.
And you think you would have enough supply for that.
Yeah.
Okay I had a couple of questions for the.
For the Covid.
The results and could you. Please comment on how long is the C. D E and the response is it particular lost.
I mean, how were really good response of your T cell response, but then.
Do you have any idea of how long it is moving from us.
Yes. This is Sean by the way of course, I shouldn't be the Guy Yeah. Yeah. We expect the see the eight responses of lots of long time and the reason why we think so because when people the admin infected with Sars.
Tobey the original Sars you can find T cell responses 17 years later, and and and cross reactive against Sars Covid. Two so we do expect that most of that one of the advantages of of T cell responses that they are long lasting we we know that the magnitude of the response as we looked at prime are pretty high and we know that the convalescent people.
And from Sars Covid, two get about a 0.2% you know and.
You know in gamma interferon response so.
Our expectation is that our responses will stay and be maintained and will be able to find themselves in and when we will have more guidance, probably later on that but we our expectations of T cells are going to be very long lasting.
Right and so and the same breadth you expect the overall protection against illness and infection of the vaccines and we expect along as well.
So yeah. So I would say you know if you're if you're talking about protection and based on that from sort of a T. Cell response, we do expect it to be long lapping a T. Cell response is not going to put net by itself will not provide sterilizing and protection, but it would protect against severe infection and hospitalizations and that's what we expect the last for you.
No quite some time and again, if we can boost the a and b your cost of responses of really robust. We also potentially can actually block of infection.
Gotcha. Thank you so much and thank you for taking my questions.
No problem.
Your next question is a follow up from Vernon Bernardino with H C. Wainwright. Please proceed with your question.
Hi, Andrea and Sharon Thanks for taking my follow up question.
The challenge is the perhaps hum ducting and optimal.
Hum and investigational and Covid vaccine study and the United States as well as many countries and the Western World, where there has already been the rollout of the authorized vaccines have you considered perhaps trying to do.
The study with the old type of vaccine.
And Brazil for example, because obviously that is a variant of concern and one and which.
And there has been very low of vaccine efficacy demonstrated by the all of the vaccine. So far that are have completed the phase III or in phase III.
So I've heard of them. Thank you for the question I'll I'll.
For the first one and I'll, let Sean and.
And I think if he wants to.
No.
From the get go a month ago, we said that our interest in the woods to conduct the larger phase two studies placebo control and looking for what I think I see all the signs of the U S. So that remains the plan.
However, the.
At this point.
As we said and the opening remarks, we see the world kind of diverging and in terms of need so.
All of the World. There is a lot of interest for one cross vary and protection and then boosting periodic boosting whether it's annual or saw and so one of the studies that we're looking to do in the developed world is to both of those that have been previously affected for the vaccinated.
And then to do the novel vaccination.
As he suggested and developing countries, such as Brazil, and India and so on.
Tom I don't know if you want to add anything.
Vernon Your question is spot on and our intention is potential is to open up regulatory.
Paths in Latin America.
South Africa, and potentially India to basically be able to address us as you suggested the strains that are emerging that are not necessarily.
Covered by the vaccine is very well and again with this product and the right. You know of cross reactive T cell response that would be of pretty good way to find and look for efficacy.
Sure Frank Yeah, I, just asked because it seems like it would be the easiest studying to do of all especially if you're going to go to a booster strategy eventually anyway.
It's it's a very good question and and strategy.
Alright, Thank you and look forward to the confusion of progress as I said thank you.
Okay.
Your next question and as a follow up from my Yang and then Tani with B Riley Securities. Please proceed with your question.
And just on the topic of the strategy I taught out of a few of this question.
What about doing a challenge study have you guys.
You know open any conversation that certain countries that have shown some willingness to.
At least be open minded to it and then my other higher level question was how how do you sort of see the broader landscape of.
The vaccines that are looking at either or other modality are going after and for being like what.
And what sort of you know you see broadly and then get peers.
So let me take the the first question.
And <unk>.
Sorry, Mike I'm, sorry could you. Please repeat the first question.
The.
<unk> Prudential of doing the challenge study like something similar to what you did and flu there used to be.
Yeah, and the cause I was thinking about you and your second question of why while for getting the first one so we've had the concrete discussions.
In some regions for where that open to doing challenge studies.
We feel like its kind of takes some time for for those for actually became a reality, but of course, we'd be very interested in doing that.
And what type of region, where they were gonna go later sort of open to doing that.
And.
And as far as for your second question and I'll, let Sean and elaborate.
We are not aware of I mean of course, a lot of oral vaccines that thought of our and relatively advanced or in the clinic.
So we don't think too much about about that the competitively some of them like if you have anything else that.
Yeah, just from the oral side of things I'd say that you know we've you know for we've been and this business and the oral tablet and for a long time and Theres definitely a lot of learning to do to get it to work and we think our technology is very important for that in terms of.
You know again nothing has been reported I think we're the first mucosal vaccine to report data as far as I know.
All of them and when its competitors come out and report data that's great in terms of and and response as well I mean, I think there's only a few other companies that are looking at and and so far they haven't reported data. So I don't have I can't really comment on you know what they've shown yet.
Understood and and actually a follow up that I just God was.
On the publication and cadence from Phase one data like how are you thinking about you know that.
Sean just kind of putting this and up the other Uganda.
And and also I know you've considered working with universities like Stanford the you know thinking about this as the Ah.
The alagoas kind of approach to a protein based vaccine and in their mind day vaccine and or even looking at studies, where you can maybe and a perspective. They look at your data and and compare it b a T cell b of Iga do you know some of these other approaches.
Approaches and the more real world setting are like when can we see some of that you know more of a more sort of a perspective and more direct comparison that we can you know and a proper study replica and George said.
Yeah, I mean again I don't think we can provide guidance on timing for these things, but we are certainly well write up of results for the phase. One study there was definitely some things and we'd like to you know finish and you know detail out before we actually go and write the manuscript and you did mention something yeah, we do have lots of friends and the <unk>.
Academic World and there is ways for us the basically just sort of look at our T cell responses in a sort of the more what I can say head to head manner by collaborating with some of the sharing samples for example, and everything else and some of those things will just take a while to of to get in place for the agreements but I.
And do expect that we will get data and coming out in Q2 without providing exact guidance at this point, but that would be that would be a reasonable expectation is that you know we'll have a lot more to talk about you know and next quarter.
Sounds great looking forward for that thanks, Thanks for taking my follow up.
Ladies and gentlemen, we have reached the end of the question and answer session and I would like to turn the call back to Mr. Andre floor of U C E O for closing remarks.
Okay.
And I want to think of everybody that attended the conference and.
And we're looking for also progressing all of all the programs.
And the two updating you soon and cause so much.
This concludes today's conference you may disconnect your lines at this time. Thank you for your participation.
And.
[music].
Yeah.
And then.
[music].