Q2 2023 Vaxart Inc Earnings Call
Yes.
Greetings and welcome to the Vacs art business update and second 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 <unk> Dot com.
As a reminder, this conference is being recorded.
I would now like to turn the webcast over to your host brand band Senior Vice President and business operations. Thank you you may begin.
Good afternoon, and welcome to today's call joining us from Docs are Andre <unk>, Our Chief Executive Officer, Dr. Sean Tucker, our founder and Chief Scientific Officer, Dr. James Cummings, Our Chief Medical Officer.
So Lee our Chief Financial Officer.
Before we begin I would like to remind everyone that during this conference call <unk> may make forward looking statements.
Including statements about the company's financial results financial guidance.
Its future business strategies and operations and its product development and regulatory progress.
Including statements about its ongoing or planned clinical trials.
Actual results could differ materially from those discussed in these forward looking statements due to a number of important factors.
Including uncertainty inherent in the clinical development and regulatory process and other risks described in the risk factors section of <unk>. Most recently filed annual report on.
On Form 10-K.
And also on other periodic reports filed with the SEC.
<unk> undertakes no obligation to update any forward looking statements. After the date of this call.
I'll now turn the call over to Andre Laurie Andre.
Thank you, Brian and thank you to all of you for joining us today.
On today's call we will highlight the recent progress we have made on our novel hardest or kill vaccine program.
We will also look ahead to all remaining planned milestones for the second half of the year and.
And basically this.
Program before opening the call to your questions.
During the second quarter, we are pleased to report positive, leaving that topline results from our phase two dose ranging study for our bivalent norovirus.
Candidates within our stated timeline.
James will want to find out if you have that data.
And what it means a lot of these potentially groundbreaking vaccine.
Important to point out that this data builds on the growing body of evidence that validates our platform actually explore the potential advantages of Nicola vaccination.
All all vaccines have designed to change that at mucosal immunity.
And this is a very important distinctive feature a powerful clinical.
Clinical data, we have generated thus far across our multiple programs.
That's because of vaccination could provide several important advantages.
But all of that across 30 on protection.
And vital mission more durable slump next time, and but all the amenities fall through the activation of both Seattle and we of course any minute.
The other important Disney channel Horn vaccine is the auto Peel format.
The old vintage diesel oral skin vaccine as fundamentals.
Making the modality equaled that have equally change, how we think about vaccines and vaccination globally.
Oilfield vaccines will allow us to vaccinate a lot more people.
They're more easily and painlessly.
Nothing that we're doing today with the injectable vaccine.
This vision is the Houston on vaccination and that's what we are working so hard to achieve.
Our cross backs that we had.
Heightened and about the potential of our novel virus vaccine program.
We believe we have the most of the bass norovirus vaccine candidates in clinical development that is both formulated for oral administration and designed for delivery to the gastrointestinal system.
Not Ohio sees a significant public health issue in developed countries and there is no approved vaccine.
More than 21 million people are infected in the U S. Each year.
Counting in them annual disease burden.
More than $10 billion in the U S alone.
And the virus continues to be a leading subject of infectious disease facilities across the country. This summer.
As the number of cases have spiteful of list three at a high.
We believe our norovirus vaccine program has the potential to address this need and the significant demand as disease burden that not all hires Karen.
Looking ahead, we have three important clinical milestones this year and we remain on track to achieve them both.
First we anticipate reporting topline data from the ongoing face the challenge of our view on one norovirus vaccine candidate in the third quarter of this year.
And then we look forward onto initiating.
This year, the Bill and Melinda Gates Foundation funding clinical trial to evaluate the ability of our motto vaccine candidate to induce anti bodies in breast milk and task.
Anti bodies to young infants.
Before I turn the call over to James I want to provide a brief update.
On our Covid program.
Today that kind of a COVID-19 vaccine construct.
Australia is a favorable immune profile.
<unk> continues to make progress on this program and we believe.
Based on that would be a causal cross Jackie can they thought we have seen in our patent concentrate.
And there may be a pathway to develop an oral and Beth I'll call them online as vaccine.
We're assessing next steps and we will provide updates as they become available.
Recently, the White House announced a new office of pandemic preparedness and response police.
We are very encouraged by the U S come from them.
Our active approach to pandemic preparedness and strongly support global efforts to get our head of the global health crisis.
Actually cope with a post emergency phase of the pandemic.
<unk> strong defenses against infectious.
Infectious diseases and others when we face.
That belief across protective vaccine could improve our ability to five future pandemics and is committed to that effort.
As you can see we strongly believe in the past one of our technology.
What it could mean for global public health and are excited for the opportunities that lie before us.
Now I'll turn the call over to James for a more detailed how do you view offered a norovirus program.
Thanks Andre.
We made significant clinical progress in the second quarter highlighted by the positive preliminary topline data that we reported from the phase two dose ranging study for our bivalent norovirus vaccine candidate.
We believe these data.
We have seen to date show promise for this vaccine candidate and more broadly our vaccine platform.
Recall that this candidate contains two Gino types G. One one and G. Two four both of which have caused the majority of norovirus disease in humans over the past 20 years.
As a reminder, this study enrolled 135 healthy adults at three sites in the United States.
The first 10 Sentinel subjects.
<unk> open label high dose vaccine.
And the remaining subjects were randomized to high or low dose vaccine or placebo.
Each of the double blinded vaccine arms had 50 subjects in the placebo arm had 25 subjects.
The primary endpoints, where safety and Immunogenicity in order to determine a dose level for phase III development.
Now, let's take a moment to review the results.
As we described in detail in our July announcement.
Preliminary results of the trial showed robust serum immune responses across all doses.
<unk> 29 relative to day one.
Both vaccine doses showed a similar increase in serum antibody responses with no statistical difference between the medium and high dose arms.
At day 29 increases in serum Iga serum IGD and BT 50 for both the G. Two four Mg one strains in the vaccine arms were similar to those seen in previous Norovirus studies conducted by Baxter.
The 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 or SaaS and no dose limiting toxicity.
Adverse event rates for both doses were similar to placebo.
I'd like to point out that the preliminary data where for serum responses.
<unk> and cell based assay data will be available at a later date.
The totality of the data from this <unk> study and the data we expect from our ongoing Norovirus Challenge study will help inform our selection of dosage levels and a larger phase <unk> study.
Could support an end of phase II meeting with the U S FDA potentially in 2024.
I'll now turn to the phase III <unk>, one one norovirus challenge study, which is measuring the safety immunogenicity and efficacy of our monovalent norovirus vaccine candidate.
This study May also help identify correlate a protection between immune responses to the vaccine and a reduction in the risk of norovirus infection and acute gastroenteritis secondary to norovirus.
Enrollment in this ongoing double blinded study is now completed.
And we continue to expect to unwind the study and report topline data during the current third quarter of 2023.
We continue to believe in the potential of our bivalent Norovirus candidate as we proceed towards a BLA submission.
We look forward to updating you on our progress in the coming months.
I'll now hand, the call over to Phil Lee our CFO for a brief discussion of our financials Bill.
Phil.
Shamed the details of our financial results for the second quarter of 2023 are summarized in today's press release.
For the second quarter of 2023, with $1 4 million compared to no revenue in the second quarter of 2022.
Revenue in the second quarter of 2023 was primarily from revenue recognized for work performed under back toward grant from the Bill and Melinda Gates Foundation.
<unk> ended the second quarter of 2023 with cash cash equivalents restricted cash and marketable securities of $67 9 million compared to $71 8 million.
March 31 2023.
The decrease was primarily due to cash used in operations as we advance our norovirus program, which was partially offset by $13 $6 million of net proceeds from our public offering completed in June 2023.
The offering extends the company's expected cash runway into the third quarter of 2024.
On behalf of all of US have effort I'd like to thank you for your time today, we will now open the call for your 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 in the question queue. You May press star two if you'd like to remove your question from the queue.
For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys, one moment, please while we poll for questions.
My first question comes from Charles Duncan with Cantor Fitzgerald. Please proceed with your question.
Oh, Hi, Andre and team congratulations on the quarterly progress.
So you know earlier this quarter, you announced the preliminary topline data from the phase two dose ranging study after the bivalent norovirus vaccine candidate.
You touched on that during the prepared remarks, when you look at the Immunogenicity data generated by the study.
You compare it to responses observed, let's say after a natural infection onto either stream. How do you feel about the response and not do the data suggest that you know you need to go lower or higher in dose where do you believe that you have.
Right those demands.
Yeah.
I'll take that one thanks so.
We're fairly pleased with the data from that study to date is consistent with previous norovirus studied yourselves and you recall that.
Preliminary topline data, we announced in July we showed robust chairman immune responses across all doses at day 29 relative to 'twenty one to me coastal in the cell based assay data, that's pending and that will be available at a later date. Once we assess that data I think we can make a stronger decision moving forward.
Alright, James Thanks.
Also what are your thoughts on one dose regimen versus a two dose regimen for this program.
I think also one dose regimen.
Alright.
And you know as we move into <unk>.
Dissipating seen data from the interim.
Average town study just wondering if you could sort of lay out.
You would like to see perhaps from a qualitative perspective, rather than quantitative that you would find encouraging and we'd like to take to the agency for the end of phase two meeting.
I don't want to project the data results before we have some certainly if we stay on track with what.
What we've seen in previous studies and notes.
Robust responses from your costumer cell based assays that would be very encouraging and then also were looking forward to the data that we should announce later in Q3 of this year in terms of the.
The neuro G. One challenge so that will be inclusive of that for a decision to be made as well.
Okay.
And then just last question sort of.
Again, I know that you have to have your end of phase II meeting.
But when.
When do you sort of anticipate or expect to operate operationalize. The next study and do you see <unk> driving the program alone forward or.
I have thought to bringing in a partner.
Yeah.
I'll take the first half second half up to Andre if that's okay. I think that from my standpoint, again, we'd like to see.
The data from this study.
As well as the detour one challenge study.
Before going.
To the FDA.
The second portion of that.
Study a larger study would then lead us to a phase II with lead us to the end of phase II discussions with the FDA and as I mentioned before.
And that could be as soon as 2020 for Andrea do you want to comment.
The second section of that question.
Sure sure.
No.
As our closest competitor or in the Novartis space.
Now, let's say.
Earlier this year.
Hmm.
Stage vaccine assets, such as the norovirus programs out of Intel.
As too many a lot of spot amongst them medium sized farmer milestone.
Well obviously.
Entertain those.
Those discussions once we have the data and as you can appreciate there are advantages and disadvantages to part of that and kind of going it alone.
Also until your comments on the ops and the five which a lot of.
Maximize value and bring them to patients.
Alright look forward to the challenge study data and thank you for taking my questions.
Our next question. Thank you.
Montana with B Riley Securities. Please proceed with your question.
Good afternoon, Deane, thanks for taking our questions and congrats on the progress so just for the <unk>.
Overland Challenge study.
Execution and enrollment has gone.
From what I can download faster than your original expectations. So could you just comment on.
The learnings you may have on executing on the study.
Thailand.
Sure.
And you get these infections and how can you apply some of this to additional.
May be challenged steady royalty you may have to do with nearby will endure.
Maybe at some point.
He came to me.
Yes.
And otherwise.
Some commentary.
And then on the <unk>.
<unk> data that you may look to report.
Incremental dose ranging.
Indeed.
Could you just remind us what you had seen previously.
There would be a drag on spread so that we're able to do on kind of bracket.
Scenarios here.
<unk> and <unk>.
And then would you look to previous guidance of then that is their medical conference you're targeting.
And then I have a financial question follow up.
Yeah. Thanks, Mike So I'll take the first portion may add.
Sean Tucker, our CSO chime in on the mucosal immunity as he is a world expert in mucosal immunity.
In terms of the learnings from the channels.
Recall that challenge studies typically.
There are much more aggressive than what you'd see in nature in the real world.
Sample size for this study was felt primarily for descriptive statistical analysis as we're looking to understand really the mechanics of how this vaccine works and to do this we have a number of measures were working at including a decrease in the severity of acute gastroenteritis, causing rmr's a decrease in viral shedding.
Our vaccines impact or effect could be on its activity and then the effect on disease severity. So these are all things I think that from a clinical or or global health standpoint are very important along with that we're looking at safety and immunogenicity.
And the potential for.
Taking a look at what our.
Our core loans and maybe it might be.
For those on the call and listening in.
Norovirus gastroenteritis is traditionally thought to be more seasonal and presentation. So you certainly have more and more of iris by and large.
For seasonal and distribution in the winter months that said there are outbreaks of norovirus, they're continue really.
Any month of the year, one only has to take a look at the CDC website here in the United States, where the WHI was very robust database or the New York times can.
It can take a look at went outbreaks occur either in nursing homes or in cruise lines et cetera. So I think that there is there is some seasonality to the traditional spread tomorrow virus, but it is a a viral infection that impacts people year round and because of that I think it will take a look at.
Executing.
Challenges in the future should they be needed.
Both Wendy Challenge model is available and we think that we have the best opportunity to recruit individuals to move forward in this study as you mentioned.
Very fortunate to move this.
This study forward and to be able to deliver.
The data on time, so we're very excited about that for the mucosal immunity question you asked specifically.
In terms of the I think the.
What we're looking at in terms of.
The mucosal immunity for the 202 study and for the 202 study, we don't yet have that mucosal immunity that will be upcoming right.
And for the historical mucosal immunity I'd ask Dr. Sean Tucker, if you'd like to just make a small comment on that as he he ran that program at the time Sean.
Sure Yeah. It's a good question. So previously we've reported that we get them. Your coastal response around somewhere between two to 10 fold increases if you're working at FICO or <unk>.
We even talked about nasal responses and you'll get a number of subjects that response.
Up to you know over 90% in terms of ASC count or.
In terms of the nasal respond well if we look at it really carefully so.
Our expectation is that the <unk>, one we will see a similar mucosal response as well.
Got it got it I appreciate the helpful comprehensive answer there so just.
Financial runway kind of extension that you guided to two <unk> next year could you clarify how much incremental non diluted funding you're baking in there from that.
Then that gave foundation or even the.
And any other forms of government funding.
Elliot.
Yes.
Sure. So I think in terms of our extended runway guidance.
Really based on our current plans and our existing <unk>.
From the Gates Foundation right. So we again once we see the data from the 201 study enrolled determining the path forward for the study then we'll kind of determine next steps and incremental spend as needed but for now it's all based on our existing plans our existing grant and no new grants.
At this time.
Okay got it. Thanks, Thanks team for taking our questions and look forward to the data historically here.
From the challenge study.
Thank you Mike.
As a reminder, if you'd like to ask a question. Please press star one on your telephone keypad.
One moment, while we poll for questions.
Our next question comes from Roger song with Jefferies. Please proceed with your question.
Good afternoon, they took the downtown La Rocca iPhone.
Thank you for taking our question.
Our first question is about the upcoming phase.
Two challenging data so could you give us some color on what what would be the go no go decisions for the two challenging data.
I can give you some color as opposed to go no go I think we'd have to talk as a team, but but certainly we're looking at.
Several endpoints and indicators so looking at a decrease in severity of acute gastroenteritis I mentioned before that a challenge study is it is very aggressive compared to what someone sees in nature. So we're trying to ensure that those who could get sick would get sick right, but we're looking for a decrease in severity of acute Castro.
Secondary to Dinara virus, potentially decreasing shedding and I think that sharing is important because that could then be somewhat of a.
Surrogate for decreasing shedding decreased transmission or you may.
Effect on activity I think is going to be very important and again I would tie that to viral shedding.
And then disease severity right so.
How it will or people actually getting I think we're looking at all of those those items along with the Immunogenicity.
But also trying to tease out if you can what are correlate of immunity might look like and I think those are the things that we're considering as we look at that dataset.
Sure. Thank you very helpful.
So.
And for the larger phase <unk> study do.
Do we have any guidance and could you provide some colors on the study design.
Sure. So I can give you some thoughts.
We would look at the evidence we see in the data.
But we are seeing from both the.
202 study that we're talking about that data and some of that data in hand, now, but waiting on the coastal Dana.
As well as the impact of the data we see from the tour one challenge study and taking a look at both of those I think we'll be able to.
Determined or helped determine what size of the study might look like one of those factors that may impact. It is if we are able to determine accordingly, right, having a correlate in hand would mean decreasing the size of if not the phase two certainly the phase III. So phase two b study would be larger you'd need to have enough people in all.
To ensure that you have a safety set that would be acceptable to the FDA and I don't necessarily want to speak with FDA, but certainly it would be larger than the study we had done now and we would be.
Ready to execute once we have those data in hand and have met internally.
Hope that answers your question.
Got it great. Thank you maybe a quick one for last.
So in terms for the pivotal phase III.
Probably you don't have much information so what what age populations would be privatized if he can.
Comment on that.
Sure.
I'll speak specifically to that question or generally about the phase III.
Again that phase III will depend on the results of the genome a challenge study.
The phase III.
<unk> study and the end of phase two meeting with the FDA, we take the guidance of the agency.
Literally to harness we're all I think interested in providing a solution for what is now one answered which is there is no approved vaccine for norovirus right I think that we can address the timing for the phase III. Once we have more visibility informed by those milestones in terms of where we're at right now.
We have tested in this study the vaccine 18 and older and I think that's what we're looking for.
As we March forward, but that would be dependent the phase III design will be depend on conversations with the agency the FDA.
Thank you I think that's all couple months. Thanks.
There are no further audio questions at this time.
I'd like to turn the call back over to your host Brent ban.
Thanks, very much so we had a lot of questions that had been previously.
Previously ahead of time on various channels.
Most of those have now been apps between Charles Mag.
M&A.
So.
Here's one.
I don't think has been empty completely yet change this one's coming to you.
Do you see any accelerated path to commercialization such as an EUA or a smaller phase III study for norovirus and what's a realistic timeline to commercialization James.
Fair enough. Thanks, Brent So we continue to address the potential options and the timing for commercialization, but once we have more visibility informed by these study results and we're just discussing now based on those results those data and interactions with regulatory agencies will determine the best plan and timeline for commercialization.
Yeah.
Well, that's fantastic James Thanks, and another one I don't think we hit during the call.
James It's also going to be for you.
Please remind us what you are looking for in the infant study and potential implications for Norovirus program James sure. Thank you. So it's unknown how norovirus infectivity.
And spread would be impacted or affected by a vaccine.
As I mentioned there is no currently approved vaccine against our buyers. However.
However.
There are some studies that suggest that if you vaccinate children.
You can also improve the health of adults.
You might not be able to protect against illness, but we know that children acquire disease and can in fact their families. So thats one of the pieces we're looking at.
Fantastic. Thanks, James So thats the majority of the other norovirus questions have been asked already and answered by you. So thank you. So much for that I think investors and people on the line that have further questions can take a look at our fireside chat platform on the investors section of our website and can go ahead and post additional questions.
And we will follow up.
Fireside chat, meaning in the near future and answer those questions. So at this point, we will close the meeting thank you.
This concludes today's conference and webcast you may disconnect. Your lines at this time and we thank you for your participation.