Q4 2020 Altimmune Inc Earnings Call

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Greetings and welcome to the Altria and year end 2020 earnings Conference call. Currently all participants are in a listen only mode. A brief question and answer session will follow the prepared remarks, if anyone should require operator assistance. During the conference. Please press Star then zero on your telephone keypad as a reminder.

This conference is being recorded.

Now my pleasure to introduce your host for today's call Ms. Stacy churches, senior director of Investor Relations and corporate Communications at helped me Stacy you may begin.

Thank you operator, and good morning, everyone. Thank you for participating and ultimate used year end 2020 earnings conference call, leading the call today will be vipin Garg, our chief Executive Officer additional members of the ultra immune executive team participating on the call today are will brown, our chief Financial Officer Scott.

Roberts, our Chief Scientific Officer, and Scott Harris, our Chief Medical Officer. Following the prepared remarks, we will hold a question and answer session. A press release with our year end 2020 financial results was issued this morning and can be found on the IR section of the company's website.

Before we begin I'd like to remind everyone that remarks about future expectations plans and prospects constitute forward looking statements for purposes of Safe Harbor provisions under the private Securities Litigation Reform Act of 1995.

Ultimate cautions that these forward looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those indicated including those related to COVID-19, and its impact on our business operations clinical trials and results of operations.

For a discussion of some of the risks and factors that could affect the company's future results. Please see the risk factors and other cautionary statements contained in the company's filings with the SEC.

I would also direct you to read the forward looking statement disclaimer in our earnings press release issued this morning, and now available on our website.

Any statements made on this conference call speak only as of today's date Thursday February 25th 'twenty 'twenty, one and the company does not undertake any obligation to update any of these forward looking statements to reflect events or circumstances that occur on or after today's date.

As a reminder, this conference call is being recorded and will be available for audio replay on the ultra means website.

With that I'll now turn the call over to Dr. Vipin Garg, Chief Executive Officer of <unk>.

Thank you Stacey and good morning, everyone.

We appreciate you joining us today for a discussion of our 2020 financial and operating results and the 2021 business outlook.

Without hesitation I can proudly say that 2020, while the transformative year, but I'll give you on and our shareholders.

Our historical development efforts laid the groundwork to enable us to unlock the value of our portfolio that would be advanced power five novel product candidates in clinical development.

I am pleased to say that each of our can debate has the opportunity to reach value inflection points in 2021 and beyond.

Not really in our history have we had such an impressive portfolio interest.

So many opportunities to build value.

As you will hear about in more detail shortly from Scott Roberts and Scott Harris.

We believe the intranasal vaccines and peptide therapeutics, we are developing may provide novel solutions to unmet medical needs and potentially have highly favorable attributes that are differentiated from existing therapies are treatment approaches.

As the pioneer of an intranasal vaccine development I'll kick me on has a rich history of vaccine innovation in this field.

Last year, we developed this expertise in response to the COVID-19 pandemic.

Our COVID-19 vaccine candidate add COVID-19.

From concept.

The clinical development and this morning, we announced the enrollment of the first subject in our phase one clinical trial.

If successful we believe that add COVID-19 could offer important benefits in.

Our fight against the Sars Covid two virus.

Unlike currently authorized vaccines.

Covid potentially offers ease of administration and deployment.

Optimum target product profile for use in pediatric population.

The potential for improved profitability on safety.

And the ability to stimulate mucosal immunity in the nasal cavity.

We believe will be critical for preventing viral transmission.

If the clinical data for that Covid parallel the preclinical findings and our clinical experience with our nasal vaccine influenza vaccine candidate ads.

That COVID-19 could become a leading candidate for COVID-19, vaccination and leave vaccination.

And with the virus continuing to mutate, creating new variance the need for improved vaccine with the potential to block transmission grid.

Growth increasingly more urgent.

Okay.

We also progressed our novel Investigational T Covid immuno therapeutics into clinical testing in 2020.

And look forward to data from our phase one slash two study.

Evaluating among other things its ability to prevent progression to severe COVID-19.

T Covid may provide a truly differentiated approach towards treating COVID-19, and we are pleased with the ongoing progress on this program.

During the past year.

We also completed dosing in a phase one clinical trial of nasal shield, our BARDA funded intranasal vaccine for anthrax, and we expect to share the data from that trial with you in the coming weeks.

Moving to our peptide based on liver disease programs, both Alt 801, and Hep D cell made important strides in 2020.

With Alt 801, beginning phase one development and have T cell advancing into phase II development.

We think Alt 801 is then specialty promising candidate.

In the metabolic disease category as a balanced G. L. P. One glucagon dual agonist.

All debt on one may have best in class attributes leveraging potent metabolic synergies and improved Gi tolerability.

Given given its platform in the drug's potential to address both Nash and obesity in a multibillion dollar market.

We're excited to see this compound advance and reach significant data inflection points this year.

Finally.

2020 was also a formidable year from a capital raising perspective.

During the year, we strengthened our balance sheet ending 2020.

With approximately $216 million in cash cash equivalents and investments.

So we are well capitalized to advance our portfolio through important upcoming value inflection points. This year.

I will now turn the call over to our Chief Scientific Officer.

Bob Roberts.

To give you an update on our pipeline Scott.

Thank you Brendan and good morning, everyone.

It's been on especially rewarding year at ultra immune from a scientific perspective.

As we deployed our expertise to initiate clinical development programs for AD Covid anti Covid do our part to help fight this devastating pandemic.

As Vipin mentioned, we believe add Covid has unique attributes that distinguish it from other currently authorized vaccines, most notably the simple intranasal dosing has potential for single dose protection.

And potential to provide both systemic neutralizing antibody and local.

On the coastal immunity in the respiratory tract.

Additionally, we've seen excellent tolerability and our nasal backs and these will shield clinical studies.

Which are based on the same platform technology is that group.

With the anticipated ability to be distributed at room temperature.

Stored in the refrigerator for years, we believe add COVID-19 could be achieve COVID-19 vaccine for both vaccination and re vaccination and could play an important role in helping facilitate and then to the global health crisis.

During the past year, we completed and provided online the results of preclinical studies of add Covid.

Demonstrating compelling results briefly these data showed strong activation of all three arms of the adaptive immune system by.

By that I mean high systemic share neutralizing antibody titers.

Robust T cell responses to the virus spike protein.

Primarily of the killer CD eight T cell types and.

And importantly, T cells of the resident memory type were also observed in the lung.

Is there to combat viral infection.

And finally, and most importantly, the preclinical data showed a pronounced reduction of mucosal Iga specific to the spike protein in the respiratory track from the single intranasal dose of Agco.

We were very encouraged by these data and believe that the robust Iga response combined with the long associated with tissue resident memory T cell response may yield an enhanced level of immune protection against COVID-19 disease and importantly transmission.

Also during the year, we expanded our collaboration with the University of Alabama at Birmingham, and established a new collaboration with St. Louis University to build on the accumulating preclinical data from <unk>.

Specifically.

These studies were conducted we are conducting with these collaborators are designed to evaluate the efficacy on that Covid and challenge models.

Demonstrate its ability to reduce viral transmission and evaluate heterologous prime boost vaccine regimens.

Data from these studies are expected later this quarter.

As you know.

The COVID-19 field is a highly dynamic and rapidly evolving landscape.

On the emergence of Sars Covid two variance is troubling and has raised concerns about the effectiveness of currently authorized vaccines.

While we are hopeful that existing vaccines will maintain their efficacy on the face of these variance we need to prepare for this uncertainty.

Importantly.

We have already initiated a development program to address these emerging variants.

Our lab is creating barrels feedstocks against the South African and UK variance among others.

And we are adapting our development plans to evaluate these new add COVID-19 vaccines and advanced clinical studies as part of our overall AD Covid development plan.

With the emergence of these variance we see the playing field for Covid vaccine COVID-19 vaccines evolving.

As vaccine developers will be required to adapt their vaccine programs to respond to these variants.

As they are Covid clinical program advances and we establish proof of concept in our phase one and phase II studies, we are positioning ourselves to advance development of various COVID-19 vaccine add COVID-19 vaccines later this year in parallel with the adaptations authorized vaccine manufacturers are making.

<unk>.

We all recognize that.

Debt, we will need to establish Curt immunity to extinguish the pandemic.

But achieving this level of immunity in the population will be challenging.

Polls have shown that there is a high degree of fear and hesitation on our population regarding vaccination.

Unfortunately up to 30% of respondents polled indicated they will not get vaccinated.

This may be influenced by reported side effects, which have been observed with the currently authorized vaccines, particularly following administration of the second dose.

It is here.

Debt or potential for improved Tolerability may be important.

The emergence of viral vaccines may create an opportunity for <unk> to be used if approved as a booster and previously vaccinated individuals to not only potentially provide protection against circulating variance.

But also to potentially provide against.

Provides the additional benefit of mucosal immunity that can only be achieved through nasal administration.

On this front, we are engaged in discussions with key players around the concept of a heterologous vaccine regimen.

Most experts believe that the <unk> could be to virus will become endemic and will continue to circulate in the population for years to come much like the seasonal flu.

Underscoring the importance and value of vaccines with improved Immunogenicity and Tolerability.

There is also a growing acknowledgement that a suitable vaccine for children.

As an increasingly important two important priority.

As demonstrated in our nasal shields and nasal vaccine clinical trials, we believe that the expected attributes of Ed Covid make it ideally suited for use in the pediatric setting.

As the intranasal administration and expected Tolerability profile are well suited to meet the needs of children.

We will remain focused on the pediatric segment of the population.

As we develop our long range clinical and regulatory strategy for Ed Covid.

Finally.

I should point out debt in addition to the attributes I've discussed.

To take advantage of that sort of getting that's going to be based on neutralizing antibodies. So that's clearly a T S.

As far as the neutralizing in the nasal cavity, that's something that we'll be looking at NAV and that's that's fine I think for the phase one a clear demonstration that we have the induction of Iga like we've seen in all of our other intranasal clinical studies.

Is expected and I think that that you need to check that box.

Rising whether or not those are weather.

Whether or not with those assets get get executed and what depending on a number of other factors. We don't see that it's necessarily critical at this stage, there's a number of other opportunities to validate the role of it in the coastal immunity. It's already been established as you know with influenza and RSV and and we're looking at those and so on the things.

One I think the presence of Iga and clearly the neutralizing antibodies and of course, we'll have the T cell data also.

Perfect. Thank you very much that's really helpful.

Thank you. Our next question comes from the line of Mike <unk> with B Riley FBR. Please proceed with your question.

Good morning team. Thanks for taking my question and congrats on the progress so maybe first focusing on the fourth quarter guidance.

Can you talk a little bit about the design of the hedge your luggage Debbie.

It seemed like you added St. Louis University and the collaboration recently can you just talk about.

What is the design.

Animal models, you are looking at and sort of what.

Helps you understand that day about the transmission blockade of actual data from that study.

Sure Robert.

Yeah, Good morning, Mike So.

And that study where the model is the transgenic mouse model, that's a model that St. Louis has been.

And using for a while and it's a very.

Very.

Expert at and what we're doing is.

Comparing the vaccine activities and efficacy of a RNA vaccine that closely mimics the on.

The RNA vaccines that are currently authorized and add COVID-19. So this will be used as single agents and then combined in a heterologous prime boost looking at the order of addition, which vaccine comes first to understand.

The overall immune responses.

Is that which order provides the best immune response.

How how best to control and and and.

Gross the replication of the virus in our respiratory track and so we're really just understanding the system of how the interaction of two different vaccines.

Proceeds obviously, if we can reduce the amount of viral shedding or replication and ideally even remove it completely that has a direct knock on effects for transmission. So that's.

That's kind of like that the 30000 foot overview for the studies that are going on there at St. Louis University.

Great and maybe on the second question if I can follow up on your comment made previously on on the FDA guidance and also on the <unk>.

<unk>.

As you think about debt NAV guidance.

The FDA guidance is not very clear in quantifying and extend that to be a positive for the field that the body is not that high but I'm just curious.

What do you think relative to natural infection.

NAV should be.

When you think about progression into the next debt any guan data or color you can provide.

I'm reluctant to do that because currently I think we're getting close to.

Having hum.

Harmonized assays performed with harmonized reagents, and so you can really do the comparisons and understand what's going on this is what they got this is what we got in a meaningful way we're not there yet the debt ratio has has released at the end of last year.

Critical reagents that are necessary. These these qualified Sarah that are have assigned.

<unk> for neutralization and ITG binding and so that's that's that's going to be critical.

I think we all have a sense of what you like.

Neutralizing titer of like 20, or something like that is not going to be too exciting, but I think we would get up into the hundreds when you compare that back to convalescent Sera.

<unk> and we can put these things in perspective.

I think to be quantitative at this stage right now is be less informative I think that we're getting close to having those types of conversations that everybody wants to have on how these things really do relate to each other but we're not quite there yet.

Got it.

Obviously.

In the context of the emerging radiance.

That could become even more interesting.

Net.

We named on lithium CNN bolted on to teams, but maybe just the final question was on the modularity of the platform.

As you saw.

From the best in any given by the French revenue vaccines on do day.

It does seem like an NOI is flat from <unk>.

Engender may not have the same timelines on which they can come.

Come on.

On the new vaccine for the variance in this day.

Curious make video platform again.

Unclear on timing, but can you provide the difference being on.

<unk> debt as part of the day NBA vaccine.

Sure So you're right the factors arent.

Arent changed as quickly as the R&D and that's why the RNA vaccines are really got the attention and the initial funding to get where they are now and that's fantastic.

The important question is no.

How quickly can we make the variance in relation to the evolving landscape.

Circulation of debt at that period, and so we can make these things.

Very short amount of time kind of on the order of a months.

And have these and have these ready and so the low.

Total dynamics in the population are not changing that quickly there's plenty of time to understand whats going on where youre doing your work and have the right you have the right vaccine. So yes, not as fast, but fast enough, yes also to that.

Great. Thanks for taking my question.

Thank you. Our next question comes from the line of Jonathan Wolfson with JMP Securities. Please proceed with your question.

Hey, good morning, and congrats on all the progress just two questions from me, we've talked a lot about <unk>, but I was hoping if you can extrapolate if things go as planned what the next steps look like in terms of our next study if that could be registrational on when that could kick off and then second question on feed on one.

Discussed on Youre expecting robust reductions in liver fat and body weight I was hoping you could help us quantify kind of expectation given the first readout will only be six weeks on duration.

Yes, Scott Harris, I think you kind of handle both of these.

Yes.

Jonathan.

No.

We are we've just initiated the phase one trial of that Covid with a readout.

That will occur.

A full readout, which will occur now in the second quarter.

We are planning right on the heels of that to initiate a phase III trial, which would probably start towards the end of the second quarter and that trial is looking like a traditional.

Phase III trial with <unk>.

Studying all age groups.

Well, it's a larger number of patients on the Immunogenicity and safety Readouts.

Regarding the second question I'm going to.

Defer to comments that were made by Juan Pablo are free ups in a recent conference call. You can also look at the <unk> data that was recently published in New England Journal on a weight loss trial that was not a nash trial with the <unk>.

Results of that trial are very similar to the Nash trial that was published at the end of last year.

It takes weeks they had a reduction of 3% now it should be pointed out that all subjects in the trial.

<unk> on a restricted diet with a net negative from 500 Kilocalories per day, as well as exercise and with even the placebo subjects in the six weeks on.

1%.

So if one were to take the 3% gross and subtract the baseline on 1% due to diet and exercise, which we cannot implement in a phase one study because it's a safety and Tolerability study.

On an efficacy trial and that we couldnt do in a phase one first in human trial, if you will.

Look at the net at six weeks it would be 2% now we think that's the floor, we think thats a minimum to show that we are at least on par with semi retired and we think we can do better.

That's very helpful. Thanks, again, and congrats on all the progress.

Youre welcome.

Thank you, ladies and gentlemen that concludes our question and answer session I will turn the floor back to Mr. Gerlach for any final comments.

Yes. Thank you everyone for listening in today, we hope you'll join US on our next quarterly earnings call and have a nice day.

Yeah.

Thank you. This concludes today's conference you may disconnect. Your lines at this time. Thank you for your participation.

Okay.