Vaxart Inc. Q1 2023 Earnings Call

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Eating and welcome to the work site business update and first 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.

A reminder, this conference is being recorded I would now like to turn the webcast over to your host Edberg Senior Vice President and General Counsel.

Good afternoon, and welcome to today's call.

Joining us from <unk> are Andres Florio chief.

Chief Executive Officer, Dr. Sean Tucker founder and Chief Scientific Officer, Dr. James Cummings, Chief Medical Officer, and Philip Lee Chief Financial Officer.

Before we get started I would like to remind everyone that during this conference call. Thanks Art may make forward looking statements, including statements about the company's financial results financial.

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 Form 10-K, and 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 Florio Andre.

Thank you Ed and thank you to all here for joining us today.

Today's call our team will highlight the progress we have made on our model.

Peter vaccine program during the quarter.

We will also discuss updates on our plans for an oil pan better coronavirus vaccine and showcase state, though that demonstrates the unique benefits of our platform.

I think with <unk>, most notably in the quarter, we initiated our phase II dose ranging study.

Bivalent novel virus, all vaccine candidates.

We remain on track to deliver on our planned milestones for 2023.

Anticipated data readout for both the dose ranging study and for our ongoing phase II Challenge study or did you on one monovalent norovirus vaccine candidate later this year.

James will provide more details on both studies in a moment, but first a quick reminder, on why this program and the studies that are so important for global public health and why we're committed to <unk> P. M.

Norovirus vaccine approach.

Norovirus is a significant public health issue, which leads to a significant economic burden in developed countries and there is no approved vaccine.

More than 21 million people are expected in the U S. Each year.

Starting in on annual disease burden of more than $10 billion.

In the U S alone.

It is important to note that not all hires predominantly affects to each segment's children under the age of high in older adults.

There are about 20 million kids in the U S and about 55 million older adults over the age of 65.

Additionally, there are approximately $15 million or there are many of them.

Who can benefit from a norovirus vaccine such as <unk>.

<unk> and child care service providers, bringing our total domestic market opportunity.

Approximately 19 million in America.

In the U S. Most people are concerned about salmonella or E coli.

But if you look at the total number of cases, not Ohio is the most frequent foodborne illness by far.

If you've been following current events Youll know that everyone is at risk cornetto by SKU.

Schools workplaces in many other places where people gather in large number.

People, who experienced norovirus symptoms are missing school and work.

And I am not able to perform their daily function.

We believe that our norovirus vaccine program has the potential to address the need and tremendous disease burden that norovirus carries both in the U S and around the world.

Today, we have produced data from six completed norovirus clinical trials that have enrolled nearly 350 subject.

These data have shown immune response heath promoter vaccine to be strong long lasting comparable to naturally infection from norovirus.

Similar in both elderly and young adult population.

You saw that generally is not seen with injectable vaccine.

In March we showcased our differentiated norovirus program.

On a virtual KOL call that we sponsored it would lead us in the norovirus vaccine development.

These experts said that insight and perspectives on the global mid quarter safe effective and readily deployable norovirus vaccine.

We hope that many of you were able to join the same format as even as we continue to educate the financial community about the magnitude of the unmet need and the opportunity for another part of the vaccine.

A replay of that event is available on our Investor Relations section.

On our website at www dot backside of desktop.

Looking ahead, we have several important clinical milestones this year and we remain on track to achieve them.

We expect to report topline data from the ongoing phase two dose ranging study or by Halo Norovirus vaccine candidate in mid 2023.

Next we anticipate reporting topline data from the ongoing phase II Challenge study of our due on one monovalent norovirus vaccine candidate.

In the third quarter of this year.

And then we look forward to initiating this year.

Bill and Melinda Gates Foundation funding clinical trial.

Finally, the ability of automotive and candidly.

Anti bodies in breast meat.

And transfer those anti bodies.

On insulin.

Taken together these milestones have the potential to support the continued advancement of Factset Norovirus program.

Towards the phase III trial.

I'll also potentially providing further validation of the promise of our norovirus vaccine platform.

Norovirus continues to remain relevant both nationally and globally and we are encouraged by this opportunity to advance our auto team vaccine technology.

Now I'll turn the call over to James for a review of our Norovirus program.

James.

Thanks Andre.

We're really proud of our clinical team for their continued efforts to advance our mission and make meaningful progress with the <unk> platform.

During the first quarter of this year, we dosed the first subject in the phase two dose ranging study of our bivalent norovirus oral vaccine candidate.

Call. It. This candidate contains two very important genotype.

<unk>, one and <unk>, four which have caused the majority of norovirus disease in humans.

For the past 20 years.

As a reminder, this trial enrolled 135 healthy adults at three sites here in the United States.

The first 10 Sentinel subjects received open label Idose vaccine and the remaining subjects were randomized to high or low dose vaccine or placebo.

Each of the vaccine arms has 50 subjects in the placebo arm is 25 subjects.

The primary endpoints are safety and Immunogenicity in order to determine a dose level for the phase III development.

Enrollment was completed in mid April .

And we expect to report topline data from this study in the middle of this year.

If successful the next step will be a phase <unk> study.

Leading to an end of phase II meeting with the FDA in 2024.

In March we announced the expansion in the number of cohorts and our ongoing phase II <unk> Norovirus Challenge study.

Measured the efficacy and safety of our monovalent norovirus vaccine candidate.

This study is also designed to identify a correlated protection between immune responses to the vaccine and a reduction in the risk of norovirus infection.

<unk> acute gastroenteritis.

Enrollment in this ongoing double blinded study is completed and we continue to expect to report top line data in the third quarter of 2023.

In April I presented on previously disclosed data from our Norovirus program at the World vaccine Congress in Washington D C.

These data demonstrate that our oral pill bivalent norovirus vaccine candidate has many broad advantages, including the following.

It induces broad immune responses.

Newcastle and systemic responses.

Immune response rates were above 90% for the high dose.

Immune responses were durable they lasted for more than 200 days.

Vaccine responses can be boosted after one year.

Immune responses in the elderly those aged 55 to eight years. In this study were very similar to those in younger adults aged 18 to 49.

And finally, <unk> norovirus vaccine has a clean safety profile and has been well tolerated in this and all of our clinical trials to date.

Next week, we'll make three presentations at the eighth International Caliche virus conference in Rotterdam, the Netherlands.

Dr. Sean Tucker, our founder and CSO will be presenting a paper on breast milk antibodies and the potential ability to block transmission.

Dr. Rebecca Flitter will present data demonstrating that boosts administration of our oral norovirus vaccine candidate at 18 months. After bivalent immunization is effective in inducing potent immune responses.

And lastly, I'll be presenting an overview <unk> bivalent vaccine efforts to date as well as providing additional details on our studies in elderly subjects.

We continue to believe in the potential of our bi valent norovirus candidate as we target a BLA submission and possible FDA approval.

We look forward to updating you on our progress as we provide updates from our concurrent phase two clinical trials.

I'll now turn the call over to our founder and Chief Science Officer, Dr. Sean Tucker for an update on our Pan Beta Corona virus program.

Sean.

Thanks, James Our research team has made tremendous strides in publishing clinical and preclinical data and presenting that data in front of important gatherings of scientific and governmental leaders.

During the World vaccine Congress last month I presented previously published data from <unk> study, demonstrating our vaccine platforms ability to block transmission and boost existing COVID-19 vaccine. We believe Baxter COVID-19 vaccine has a favorable immune profile achieving all of the following objectives.

It is room temperature stable it is easy to administer it induces serum antibody responses and serum neutralizing antibody responses.

It induces potent T cell responses it creates a mucosal immune response.

Okay virus transmission.

It is cross reactive it against Sars Cov, two variants and other beta coronaviruses.

And importantly, boost the most important COVID-19 vaccine.

Based on all of Mucosal Cross reactivity data, we have reported to date in our Covid clinical vaccine study. We believe we may be able to create a oral pan beta Corona virus vaccine. We continue to develop new construct that enhance pan beta Corona virus Cross reactivity and we plan to advance these to the.

When we are ready.

That's a vaccine would make it easier to both protect against current circulating viruses and to future proof the vaccine either against emerging coronavirus threats or other beta coronaviruses.

Making it a valuable tool for pandemic preparedness.

We believe this approach makes tremendous sense. There is continued interest in next generation COVID-19 vaccine from regulatory and governmental bodies as evidenced by the Baidu administrations reported proposed commitment of up to $5 billion.

Such next generation coronavirus vaccine.

We look forward to continuing to gauge with the government with the goal of obtaining funding for our Pan banner Coronavirus program I'll now turn the call over to Phil for a discussion of the financials Bill.

Thanks, Sean the details of our financial results for the first three months of 2023 are summarized in today's press release.

<unk> ended the first quarter of 2023 with cash cash equivalents restricted cash and marketable securities of $71 8 million.

Compared to $95 7 million as of December 31, 2022.

The decrease was primarily due to cash used in operations as we advanced our norovirus program.

We continue to expect our current cash position provides us with runway into the second quarter of 2024.

On behalf of all of us that backfire.

Like to thank you for your time today.

We will now open the call for your questions.

Okay. So you would like to ask a question. Please press star one on your telephone keypad to ask a question.

One on your telephone keypad and it looks like your first question is going to come from Ryan Goodman Tani with B Riley.

Ma'am your line is open.

Good afternoon team. Thanks for taking our question. So you seem to have the money.

Joining this effort to develop a norovirus vaccine, which validates the disease burden and market opportunity that you guys have been talking for a while and you obviously.

We're miles ahead here in terms of being in phase two could you just talk a little bit about the platform differences advantages.

Relative.

Your platform relative to <unk>, and then I have a follow up.

Okay.

Hi, Mike Yeah.

Yes, let me tell you a little bit about obviously I think our platform will be very good from the standpoint of listening antibody responses in mucosal surfaces and certainly norovirus is pumping in fact intestinal state. We do know we make very strong intestinal antibodies because we think we have an advantage as you know mrna vaccine can be very good.

Arum antibody responses, but those tend to be a little more transient I think our data at least in norovirus is that we can at least have our antibodies in the Sierra last for more than 200 days. So I think you know I think we have some significant advantages and obviously we're further ahead.

Great and then on the challenge study Furthermore in overland.

We do sort of comment on how the sort of the expectation of events that you had.

When we designed this study relative to sort of where you are.

Anything else that you guys have learned as you have been executing on this study.

So as you know there's no blood that'll be great and thanks for taking my questions.

Why don't I take this one Sean this is James so.

Call It challenge studies.

Typically they are more aggressive than what you see in nature in the real world occurrence disease. The sample size for this study is still primarily for the script is statistical analysis as they are really looking to understand how the vaccine operates to do this we have a number of measures, we're looking at including but not limited to a decrease in severity.

Of AG or acute gastroenteritis, a decrease in viral shedding.

Second <unk> activity and the effect on disease severity.

Got it thanks for taking my questions.

Okay, Okay Minder, if he would like Jack.

Question. Please press star one.

Our next question is going to come from Roger song with Jefferies.

Your line is open.

Great. Thanks for that and we're taking a question.

A few quick ones from us so the first one for that.

By Balan Immunogenicity data in mid year.

So can you just let us know what is the expectation for that data and how you're going to make the.

Go no go decision forward.

And understanding you will potentially do a phase II b, what will be that the <unk>.

Attention a study design for that based on the phase two.

The data you will see mid year.

I have a follow up after that thank you.

Hello, Roger This is James so I'll take a stab at that for these phase two are 202 Norovirus study, we're looking at the safety and Immunogenicity of two different dosage strengths of our bivalent construct.

And we will take a look at both the safety, which today knock on wood is looking just as our portfolio has in the past well tolerated, but we'll also look at Immunogenicity and compare those two groups.

Those are sort of the two things we will look at to judge what dose to take to the larger study the phase II b. So that we can get enough safety data.

Then I have a follow on discussion.

Phase II discussion with the FDA and.

The follow on to that study would likely take a few months. So we would project if all are successful potentially 2024.

Got you.

Then so given you will have the challenge of study data.

From a mono <unk>.

The phase two b.

For the Bivalent do you expect you will also do something similar.

Tenda study before you.

Moving to the pivotal or you will bring the bivalent with larger phase <unk> data with Monovalent challenge of data and are moving into that phase phase III pivotal.

Well I think the sequence of events are such that we will have the topline data from the 202 study the phase two dose comparison study part a.

Mid year.

As we said in this.

The conversation, we will have the topline data for the challenge study.

In Q3 of this year. So those two data points are fairly important as we map out our next steps.

Does that answer your question, Roger because I'm not quite sure if I got that.

Yeah just.

Also the question, but just curious.

Do you need another changes for your bivalent before you can move into later stage development.

Yes.

Yes, I think that's a discussion to have with the regulatory agencies. After we have this data.

In terms of additional studies.

Whether or not that's a requirement or not is something that we'll talk to be talking to the agency about.

Thank you.

Okay that concludes the audio portion of the Q&A. So I'll now turn now over to Greg for the written Q&A.

Thank you.

We've had a number of online questions.

James This first question is for you.

Did you have additional discussions with the FDA this quarter and if so what was the context of those discussions if any.

Thanks, Ed.

Had not planned for formal discussions with the FDA this past quarter and really haven't had a need for any discussions in the past quarter, but we do plan for a post phase II meeting with the FDA once the larger phase II <unk> studies completed as I mentioned to Roger.

Thank you.

Also on the subject of norovirus.

This question's for Sean.

How important is identifying correlates of protection to the overall norovirus program and a follow up question to what what could identifying this correlates tell you about the vaccine candidate and probability of success in phase III.

Thanks, Ed, Yes, certainly understanding what immune parameters it reflected the success.

It is important for speeding up the clinical development helps you know what to look for in late stage trials and helps you understand it but any changes you're making dose vaccination schedule can positively impact efficacy of course that does not have to have but it's certainly nice to have because it can speed up your trial and definitely reduced the size of your.

And your phase III study.

Thanks, Sean.

One more question on the Norovirus program.

This one is for James.

Wood herd immunity have a role for norovirus.

If you vaccinate infants with adults be protected over time.

Yes, that's an interesting question.

It's unknown, how norovirus since activity and spread would be affected by a vaccine because as you know there is no currently approved vaccine out there.

Sure there are several studies that inform us.

That if you vaccinate young children, you also improve the health of adults.

There's a relatively well known study.

Can that showed when a young children were vaccinated for influenza.

The rate of death for all causes are all cause mortality in the elderly population decreased significantly.

You might not be able to protect against all illness, but we know that children acquire disease, and then transmit to their families and that's a portion of.

Global health that we hope to address.

Thank you.

We have a question. The next question is on the coronavirus.

The Covid program, we have and that actually is I think Sean and Andre you might want to answer. This question is that the Washington Post reported on the Baidu administration RFID for next generation Corona virus vaccines and the report referenced a potential $5 billion in funding.

Does the by the administration Nextgen vaccine proposal change at all how Youre thinking about the Pan data Corona virus program that you referenced in the call.

Yes, that's a good question again the reported potential funding for next generation vaccines as a positive that I don't think the announced that changes our approach, but it is probably reflected that the consensus of the scientific community and improvements to the current vaccine can be made.

Andre.

Yes.

As to what Sean said is is that we.

We see this progress on the Baidu isn't it.

Okay.

Shinohara approach.

And as people that have not yet if I can attest that we feel like.

The requirements on the Hopewell saw Niccolo immediately did very well.

Platform. So we are quite encouraged.

By these initiatives and we're looking to see.

Seeing how we can.

Participate in it.

Thank you Andre.

<unk>.

One final question this one's for Sean again on Covid do you have a timeline for advancing a Pam beta Corona virus vaccine candidates in the clinic.

Yeah, I mean, certainly we are continuing to develop newer candidates and concourse construction research, which we believe have increased potential to make a potent pan beta coronavirus vaccine.

Not providing any guidance at the time again timing depends on multiple factors.

Okay.

Okay. That's all the questions we have.

I'll turn it back over to the operator.

Okay. Thank you that concludes our call you may now disconnect and thank you again for joining.