Q2 2022 Enanta Pharmaceuticals Inc Earnings Call

Good afternoon, and welcome to E. Manta Pharmaceuticals fiscal second quarter 2022 financial results Conference call. At this time, all participants are in a listen only mode. There.

It will be a question and answer session at the end of the prepared remarks. Please be advised that this call is being recorded I would now like to turn the call over to Jennifer Viera Investor Relations. Please go ahead.

Thank you operator, and thanks to everyone for joining us this afternoon.

The news release with our fiscal second quarter 2022 financial results was issued this afternoon and is available on our website.

On the call today are Dr. J, Lullay, President and Chief Executive Officer, Paul Mellett, Our Chief Financial Officer, and other members of Anantha Senior management team.

Before we begin with our formal remarks, we want to remind you that we will be making forward looking statements, which may include our plans and expectations with respect to our research and development pipeline and financial projections all.

All of which involve certain assumptions and risks beyond our control that could cause our actual developments and results to differ materially from those statements.

Ascription of these risks is in our most recent Form 10-Q and other periodic reports filed with the SEC and the answer does not undertake any obligation to update any forward looking statements made during this call with that I'd now like to turn the call over to Dr. Jean Louis <unk>, President and CEO Jay.

Thank you Jennifer and good afternoon, everyone.

Last quarter was an important one for our nantong during which we made progress in our pipeline and advanced our mission of developing therapeutics for life threatening viral infections.

This progress comes at an important time as we are soon approaching meaningful inflection points in our pipeline today.

Today I'll start by detailing our most advanced programs in respiratory virology, where we continue to build an industry leading treatment portfolio.

Respiratory syncytial virus or RSV can result in a severe respiratory infection and is associated with significant morbidity and mortality.

The virus can cause serious disease in children, the elderly and the immune compromised and there are no targeted treatments or vaccines available.

Our robust RSV program includes Edp 938, the most advanced in protein inhibitor in clinical development today.

As well as our newest clinical candidate Edp three to three <unk>.

L protein inhibitor.

We're excited by the potential of Edp 938.

Which currently is in three phase two studies in different patient populations.

Edp 938 is an oral potent molecule that has shown robust clinical data in our phase II Challenge study, where it was safe and well tolerated and resulted in a significant decline in viral load and reduced symptoms of infection.

Our leadership in RSV is further highlighted by the recent publication of the results of the challenge study in the New England Journal of Medicine.

Our most advanced study of Edp 938 is RSP P. A phase two b trial in otherwise healthy adults with community acquired RSV infection.

Study was designed to confirm in a community acquired study and the positive results of our Phase Iia Challenge study and to further characterize its efficacy by measuring symptom alleviation and viral load decline.

Enrollment in RSVP is now complete we are on track to report top line data from this study later this quarter.

Our two other ongoing studies or RSV peds, a phase two study in pediatric RSV patients at RSP T X a phase <unk> study in adult hematopoietic cell transplant recipients with RSV.

Both are expected to recruit into 'twenty 'twenty three.

Moving forward, our broad clinical development pipeline for Edp 938 will focus on evaluating its potential in populations with greatest unmet need.

Namely those who are at high risk for severe disease. This includes children the elderly adults with other high risk conditions and the immune compromised.

To that end, we are also planning to initiate another phase two b study in high risk adults, including the elderly and those who have asthma C. O P D or congestive heart failure, we expect to initiate this study in the fourth quarter of this year.

We're excited to add this study to our clinical development program as we believe Edp 938 has potential to deliver a potent oral antiviral treatment for all high risk populations.

Indeed, we believe these high risk patients would benefit the most from antiviral treatment with Edp 938, they represent populations in which an even greater benefit is likely to be observed since they have suboptimal RSV immunity and manifest much greater RSV disease severity and mortality.

Bowing demonstration of the full potential of Edp 938.

Adding to our robust RSV portfolio.

In February we introduced Edp 323, our novel oral antiviral therapeutic targeting the RSV L protein RNA polymerase.

Preclinical data have shown that Edp 323 has sudden animal or in vitro potency against major subtypes of RSV RSV, a and RSV b and is not expected to have cross resistance to other classes of inhibitors.

Additionally, in preclinical studies Edp 323 has shown strong oral absorption and good plasma exposure across different species.

We believe Edp 323 could serve as a standalone treatment.

Or may be used in combination with other agents such as Edp 938 to potentially broaden the treatment window or addressable RSV patient populations and we plan to initiate a phase one study of Edp 323 in the second half of this year.

Turning to Sars Covid, two we're making strong progress with Edp 235, our oral inhibitor of the three C. L. Protease also referred to as the main protease where M Crow.

D. P 235 is specifically designed to be a once daily oral treatment for COVID-19, without the requirement for Ritonavir boosted.

Novel variance of Sars Cov, two are continuing to emerge, causing new waves of COVID-19 cases globally.

This highlights the need for conveniently dosed oral therapeutics, especially given the suboptimal vaccination rates decreased protection against new variance and.

And waning immunity observed to date with the current boosters.

We believe Edp 235 has the potential to be a best in class treatment for COVID-19 based on the preclinical data demonstrated to date, which positions. It amongst the most potent direct acting antivirals currently in development for Sars Cov two infection.

In March the FDA granted fast track designation for Edp 235, further highlighting the potential for Edp 235, and emphasizing the urgent unmet need that exists for COVID-19 treatments.

Last month, we presented data on Edp, two three fives in vitro pharmacology and molecular mechanism of action at the annual meeting of the American Society.

Society for biochemistry and molecular biology.

These preclinical data demonstrated that edp 235, as a potent inhibitor of Sars cov, two three C. L pro with Nanomole or antiviral activity against Sars Cov, two variance of concern, including the Delta and Omicron variance.

D. P. 235 also showed potent antiviral activity against most other pathogenic human Corona viruses potentially making it a pan Corona virus therapy.

We are on schedule to report preliminary data from our phase one study of.

Of Edp 235 later this quarter.

This first in human single and multiple ascending dose ranging study is evaluating the safety Tolerability and pharmacokinetics of Edp 235 in healthy volunteers after once daily dosing without ritonavir.

If supported by Phase one results, we plan to advance Edp 235 to the next stage of clinical development in the second half of this year.

We also continue to pursue our respiratory discovery program in human Metapneumovirus or H M. P V.

A virus that is similar to RSV and impacts a number of vulnerable populations, including the elderly adults with underlying pulmonary disease and those who are immune compromised.

We are nearing completion of lead optimization of potent and animal or H M. P V inhibitors and plan to select a clinical candidate in the second half of this year.

Moving to hepatitis B, we remain committed to developing a combination regimen is a functional cure for chronic HBV patients.

Edp five one for our core HBV core inhibitor with fast track designation has demonstrated safe and potent antiviral activity and two phase one studies in different chronic HBV patient populations, those who have high viral load, whom we refer to as viremia patients.

And those who are on a treatment with a nucleoside reverse transcriptase inhibitor, whom we refer to as nuc suppressed patients. These data suggest edp 514 has the potential to be a best in class core inhibitor for HBV.

We remain focused on evaluating internal and external opportunities for additional components with alternative mechanisms to develop in combination with Edp 514, as we believe that a core inhibitor such as Edp 514 will ultimately be an important component of a successful combination regimen.

Before moving to the financials I'd like to wrap up by highlighting our near term milestones. We plan to report data from RSV P. This quarter and look forward to initiating a new phase two RSV study in high risk adults by year end wed.

We expect to report preliminary phase one data for Edp 235, our oral antivirals specifically designed for the treatment of COVID-19 later this quarter.

If indicated by phase one results, we plan to advance Edp 235 to the next stage of clinical development in the second half of this year.

We also look forward to initiating a phase one study for Edp 323, our RSV L inhibitor as well as nominating a clinical candidate for human Metapneumovirus in the second half of this year.

With that I'll turn the call over to Paul to discuss our financials Paul.

Thank you Jay.

I'd like to remind everyone that a natural reports on a September 30th fiscal year schedule.

Today, we are reporting results for our second fiscal quarter ended March 31, 2022.

For the quarter total revenue was $18 7 million and consisted entirely of royalty revenue earned on as these global HCV product sales of $380 million.

This compares to total revenue of $20 1 million for the same period in 2021.

This decrease is due to the treated patient volumes continuing to remain suppressed compared to pre COVID-19 levels.

Abbvie has guided to $1 7 billion for global HCV sales in calendar 2022.

As a reminder, our royalties are calculated on a calendar year basis, therefore royalties for our fiscal quarter ending March 31st will be calculated at 10% our lowest royalty rate tier in our fiscal year.

You can review our royalty tier schedule in our 2021 Form 10-K.

Moving onto our expenses for the three months ended March 31, 2020 to research and development expenses totaled $42 1 million compared to $41 5 million for the same period in 2021.

The increase was driven by the timing of manufacturing and clinical trial cost associated with the company's virology and liver disease programs.

General and administrative expense for the quarter was $10 5 million compared to $8 3 million for the same period in 2021.

This increase was primarily due to increased head count and stock related compensation expense.

And Andrew recorded no income tax expense for the three months ended March 31, 2022, compared to an income tax benefit of $7 1 million for the same period in 2021.

And then to recorded an income tax benefit in 2021 due to the provision of the cares Act of 2020, which enable the company carried back its tax loss in the 2021 period to offset taxable income in prior years.

This provision does not apply to periods ending after September 30th 2021.

Net loss for the three months ended March 31, 2022 was $33 6 million or a loss of $1 63 per diluted common share.

Compared to a net loss of 22 million or a loss of $1 nine per diluted common share for the corresponding period in 2021.

And as it ended the quarter with $322 5 million in cash and marketable securities.

<unk> expects that its current cash cash equivalents and marketable securities as well as its continuing royalty revenue will be sufficient to meet the anticipated cash requirements of this existing business and development programs for at least the next two years.

Further financial details are available in our press release and will be available in our quarterly report on Form 10-Q when filed.

I'd now like to turn the call back to the operator and open up the lines for questions operator.

Thank you ladies and gentlemen.

At this time, you won't need to.

<unk>.

Eastern.

Boston.

No first question coming from the line of Brian <unk> with Baird. Your line is open.

Hi, This is Luke Harman on for Brian . Thanks for taking the questions. Just a few on Covid could you discuss your current stance regarding potential for invasive mutation of the main protease to reduce the anti viral impact of the existing our existing tea ice or U D. P 235.

Is there anything specific about the healthy volunteer data you think could be particularly informative about a potential advantage over the competition at this point. Thanks.

Hi, Thanks. This is Jay speaking.

So with regards to resistance.

We wouldn't expect to see much in an acute infection.

Like Guam.

Cobalt or even.

In some instances, perhaps RSV if you have.

No good robust molecule going after the drug when it's only going after the virus, it's the only one.

Days of treatment.

I think that that pumps metal mine swings a lot I don't think Pfizer has has reported anything at this that's up now.

With regards to the healthy volunteer study absolutely you want so it will be we'll be looking at will be looking at safety, but of course first and foremost making debt demonstrating good safety profile.

And we'll also learn a lot from pharmacokinetics.

I think again the.

The goal here really in this COVID-19 proteins space to try to come up with something that's a very convenient not only for the patient, but also for the health care provider.

Treating the patient.

Well to that in something that's a once daily dosing.

And once daily dosing without a ton of or boost unless you know retirement here and it's a lot.

Sort of complexity.

To the to the patient care so.

Those are the main points I think will be oriented.

Healthy volunteer study.

Great and if I could just ask one more could.

Could you just provide any color on what a phase two design might look like at this point or is that too.

Be announced.

Well, it certainly it'll be to be announced.

In future we havent.

We were you know sifting through all of that right now and in the context of the changing landscape.

Oh, yeah ultimately.

Ultimately.

As you know common to go in and take a look at any viral activity.

So I suspect there's a good chance, we'll be doing some of that.

That's helpful.

Rollout activity and then having discussions with our regulators.

Two final ones for Paul.

Gotcha, Thanks, I'll hop back in queue.

And our next question coming from the line of Brian Abrahams with RBC capital markets. Your line is open.

Hi, good afternoon. Thanks for taking my questions. Two from me I guess first off on 938.

What's the right way that we should be thinking about the potential translate ability from the RSVP data to a higher risk population that youre going to be testing. Subsequently I'm. Just wondering I guess, if there's differences in immune impairment that might change the impact at 938 might have on viral load or on <unk>.

<unk> between the two populations and then my second question is on two to three five.

There's been some I guess anecdotal reports on rebound from <unk>.

And also some recent prophylactic data that didn't quite hit statistical significance. So I'm curious if those evolving data points I guess, how those shaped the way you might think about a development and regulatory path for two to three five with respect to the doses durations and populations you might study to most to best elicit its potential differentiation.

Sure so addressing nine crude on the translation again where is.

As you know, we're kind of on the heels of some.

Very strong data.

Human Challenge study, which of course was in healthy volunteers, who were infected with virus all in flux, but with some strain in the same level of inoculate them on that.

Ultimately.

Oh treated and what we saw was a dramatic reduction.

Sometimes we saw a dramatic reduction.

Viral load.

And so RSVP stops into the real world.

We're dealing with are not <unk>.

There's similar patient population or otherwise healthy volunteers or adults.

And the you know the big differences.

How did they contracted the virus.

What was the strain was a degree of a lock him out of them and so on and so forth.

But one of the gating items is the.

The emergence of sometimes so that's sort of a grand Unifier one one more patient population those London, sometimes emerge and then you know getting people dosed and treated with one of the first 48 hours post symptom onset.

So I would.

Okay, Great translational study going from a challenge study to the real world.

It's a slightly different patient populations on others in the real world. So.

Obviously, we have some.

A transplant study going on where people are compromised.

We have.

Pediatric study.

And young children, many of whom have them.

Suppose before them.

And our lobbying expose.

You know later this year, we're going to have an study in high risk.

Dulce adults, who are elderly or oh, another issue going on the puts them on high risk and RSV infection study.

So each one of them is a little bit different but I think.

You're gonna be firmly grounded.

On.

The fundamentals the path.

<unk> has a very strong teekay.

He will be a good exposures half life.

Siemens is very potent drug.

So all of the things all the boxes that you could check along the way.

Our in place.

Thank you.

These are tremendous confidence building steps and.

Mentioned, you know could there be a.

I would say the most different inclusion population is perhaps the immune compromised, where obviously you don't have that helping him to be.

And the immune system.

Pudding.

Putting working alongside me on T viral so.

To that end, we're mitigating some of that point.

29 days longer duration and ultimately in severe immune compromise you know maybe that will.

In a rare instance, a spa and the need for a combo with a molecule for example, like ETP through Q3.

So.

And you know that's about as good of a interesting translational.

Confidence building stock.

As you could do but you.

You know in these high risk patient populations I'll remind you.

That they're at high risk.

Sort of goes without saying, but often the the viral loads are higher one off on the duration of infection is longer.

And often the consequences along the way.

More substantial so it will.

I think be an ideal backdrop for our strong antiviral to really showcase.

You know in effect.

Well not high risk patient population.

So steady as she goes.

You had a question a couple on the cloud globally.

I think what one one it's about.

It's fairly rare I think of those.

Sort of rebound sometimes in patients.

So one can think about a different durations I think.

The duration of five days.

But pfizer used.

I think there was some discussion in the plays or arena and some recent discussions from regulators recently around the claim type stuff.

But you see such a thing shouldn't you be dosing.

With another five day of course, I think that was recommended against at least you know now that it should be fine dosing with the first course and then Linda.

Rare instance, where.

Something appears.

Later.

It's probably not enough of a deal to really focus on and off.

Further treatment.

Obviously will be pre <unk>.

I've seen our molecule.

It's wide open in terms of the market.

The latest and greatest on that front, but I think that's the state of play.

On that did you have one other question Juan Pablo.

Yeah.

Well I think you kind of covered it but I was just getting at some of the possible shortcoming that are beginning to emerge and maybe some slightly disappointing data on the prophylactic side, if that sort of changes how you might get to three five for future development to most differentiate it and maybe take advantage of some of that.

Central advantageous properties like like potency.

Got it.

Well I think a niche.

On the.

Let me sort of a.

Standard risk lower risk patient population I think people are still trying to sort through what are the best endpoints to be looking out. There you know I think Pfizer Oh, there had their run audit with some fairly stringent.

And points in your question losses, without what will that set of endpoints looked like in the patient population as the virus continues to.

Of all you know.

Well, we'll be paying close attention.

Too bad.

The same is true with post exposure prophylaxis again some of the first trial information is starting.

Starting to come out, but I think.

Figuring out the dynamics.

You know how and when.

You know to get that drug on board to make a difference in that patient population. These are all things to sort out.

But having one that is.

More accessible.

And easier to use without.

Limitations based on where autonomy or D. D is with other drugs you know, it's it's one thing if you're trying to.

To treat a single patient who was infected.

It's another to prophylaxis and then bring it into a broader swath of family members or their close contacts where each of them might have different circumstances that are confounded by recalling appear so each one of those things would need to be carefully thought through and sort it through and Meanwhile, the clock is ticking so.

You want to.

You want to try to mitigate that by getting.

People on drug as soon as possible and that's why we're really focused on.

Things that are easy to use and hopefully you know what.

Every time.

Makes sense. Thanks, so much Jay.

Youre welcome.

Our next question coming from the line of Yes mean jami.

Your line is open.

Hi, This is Rob Malone for it yes, I mean, a couple of questions for us. So we are we have been speaking with experts and kols in Proteus and directors, who suggested that the reconnoiter boosting might be a critical component to maintain efficacy, especially in light of growing idiots. So do you like how.

Concert and like what gives you confidence that 235 and market need unequivocally the boost and could have a similar efficacy.

And then second question is like a God junction do you plan on partnering this asset and if you could walk us through the decision tree of liquid in that that could happen. Thanks for taking the questions.

Sure. So I mean, we're talking of Aaron's Inc.

I mean, we know what.

What the drug did without retarded here all the.

The spectral world. So I believe it was.

It was.

Three times, a day dosing in over a gram.

Dosing and so forth and I think someone made the call that.

In the Grand scheme of things it would be better to do a ton of air boosting in order to get adequate.

Drug exposure, the B I D regimen would be.

Acceptable.

So there's no magic about it I mean, it's an HIV drug.

And boosting agent boost lots of drugs and that's.

Both the benefit on the AR and the <unk>.

Confounding element, if we're trying to reach them. So if you can demonstrate.

You know similar.

Or better PK and you don't need we're trying to do here than theirs.

There's no reason.

There's no reason to use it.

And so that's that's the angle that we're exploring obviously.

That product profile tests very well.

And we you know we're in the process of sorting that out even as we speak.

With regards to partnering.

You know I've said previously that our expectation is we will team up.

This is a global pandemic.

No.

Other than we are so to speak and I think no to that and much like we did in the area of hepatitis C to take on a really global problem like that just made a tremendous amount of sense to us.

You know too.

The team so we.

Our plan is to do that.

And our plan is to do that you know really in times such that.

You know when it comes time for global supply chain.

That a global launch.

That we are that we're well partner dog.

In terms of supply chain for our clinical trial supply through registration.

All of that under control, we're thinking about the trends you know after that.

And.

And.

That's where.

Giving given the timing and often a compressed timeline to find themselves, but we'd be looking to do that.

Sooner than we might have otherwise.

So.

But it's definitely in the plan.

And our next question coming from the line up.

Hawaii with Jefferies. Your line is open.

Hey, guys. So given the RSVP study completed sometime in January is the C suite fully blinded to the data at this time and if that's the case what gives you the competency initiate the high risk 30 before getting a chance to look at the RSVP data.

Additionally, I noticed on the press release today, you mentioned RSVP was running a low risk and otherwise healthy population and is it fair to say the chances of outright success for this trial are low given the background patient dynamics. Thank you.

Yeah, so they're there.

Thanks for the question I mean, it brings up an interesting point.

You know these the progression beyond RSVP.

It's sort of independent.

Independent as we can.

Look with these high risk patient population of course, we're looking to.

You know demonstrate safety.

And Ah patient population and also hopefully.

Symptom reduction.

And viral load changes, but.

When you look at high risk patient populations as I mentioned before.

Got a bigger dynamic window, maybe this is getting a quick question about the.

Hmm.

The.

The low risk.

Low risk and high risk.

And the Covid case no people.

Great.

You can see on high risk patient populations without doing it and when lower risk I think in part.

It has to do.

With the dynamic range and the endpoints that you were able to work with.

No.

Again, I think it's an interesting translational study.

But.

No.

Do them independently.

And our next question coming from the line of Robert.

<unk> with JMP Securities. Your line is now open.

Hi, Thanks for taking the question just a couple quick ones for me that I'm on the RSVP study J I think you've said designed to show a 40% benefited just wanted to check that that 80% or 90% powering.

It's an 80% power to show a 55% effect.

Okay, Okay and the.

So, but the minimal separation or effect size that you can detect.

And with the sample size is 40% reduction.

As long as the final result show a 40% reduction.

This study will be positive.

Okay.

And then for the Edp 235, the phase one later this quarter or do you have you said preliminary data I just wanted to check are we going to get both the single ascending and multiple ascending.

This quarter or is it just the single ascending.

So we should have we should have most.

Cohorts from let's say D and there may be.

We'll see if we have all but we should have most of them.

Okay, great I'm going to throw in one more I guess that the RSV Peds study is it stratify them between hospitalized and and non.

Clinical trials Gov, I don't see a specification between upper and lower a rest.

Respiratory tract infections at stratify them by that.

And then I guess is it safe to assume that the hospitalization would imply a lower respiratory tract infection. Thanks.

I'll, let actually I'll, let Natalie answer this one.

Hospitalization part has.

In part because again this is the first study in peds, when youre going to do it.

And a very careful environment. So that's the nature of the hospitalization.

Not only do you want to comment on any strategy yeah sure. Thank you Jay I can just continue on that Dan says so there's no sort of Teekay says you know first in pediatric study and there wasn't any requirement from linking it to me because its actually purposes.

And there was necessarily just for the first cohort I'm.

So it doesn't mean necessarily that the kids will come we then they all carry.

Got it thank you.

Welcome.

And our next question coming from the line of Eric Joseph with Jpmorgan. Your line is open.

Hi, This is Hannah on for Eric Thanks for taking the questions. So first just can you talk a little bit about some of the gating items to reporting data from the RSVP study enrollment has been completed.

At the end of last year and just wondering if there is any work left to complete prior to announcing that data.

And then also your printing to initiate in the RSV P study or the RSV study in older adults at high risk by the end of the year just wondering.

For like kind of timeline would you be anticipating being able to complete the study within all RSV season.

What's your dataset. So much studies would you need to have in hand.

Or initiating phase three pivotal study thank you.

Yeah.

Sure so.

Sure.

With regards to the high risk patient it's.

It's a study again well we'll get started in.

In the second half of this year.

Well historically, it's been almost impossible for anyone to them too.

Accrued a season or a recruited.

And exactly in one season, certainly in one North American season.

Now as you know we started in northern hemisphere.

Sure.

Really just kind of depend on what RSV rates look like in terms of the speech of enrollment so how do we get onto the actual season.

Really hard to provide.

You know granular guidance the good news, though is that as we roll through this study we have a pretty good sense as it as we go.

This study should enable a phase III registration study.

But this.

This is something that we'll discuss.

With the.

The agency is as we.

Having an end of phase II meeting.

I think the what was the other question about RSVP.

The study did enroll finish enrollment.

Late last year.

Yeah, and I think one of the gating items was pulling on all the.

Virological data.

<unk> from a.

From from an outside vendor who is doing the clinical virology, so it's really related to that but we're.

Yeah, we're on track to report our top line this quarter.

So just to follow up on just pivotal I'm thinking about depends on design for RSV.

So with each phase two study the band plan to evaluate.

All they have an opportunity in that setting or would you wait until all three studies are completed.

Well I guess I'll Fortunately no we wouldnt wait.

We would definitely not weight.

Thank you.

Youre welcome.

And our next question coming from the line of Jay Olson with Oppenheimer. Your line is open.

Oh, Hey, thanks for the update and thanks for taking the questions.

<unk> RSV, how are you thinking about monotherapy versus combination opportunities in.

Various different patient populations and what's the best strategy to advance both 938 and $3 23.

Oh sure I don't actually I mean.

This shift on over to Tara Keefer.

To chat a little bit about that strategy.

Sure No problem Hi, Jed this is Tara. So we're we're certainly looking at three to three is that advances into the clinic and we will be now looking at that and in a typical phase one study and then.

Understanding a little bit more about the characteristics and antiviral activity on its own and then thinking about potential combinations down the road with 93 eight.

And that would be either too you know look at different patient populations or potentially.

Extending the treatment window, you know the opportunity of when we're able to treat patients after symptom.

Onset and so it will be you know will be thinking about how best to bring both of those compounds forward alone and with cutting through might try in combination, but certainly both compounds have.

The ability and the profile to to move forward as a monotherapy and in settings, where we.

I want to look in the nation.

Great. Thank you.

Could I ask a follow up on 235.

Do you expect $2 35 to benefit from an emergency use authorization and also will future studies of $2 35 require an active control arm.

So.

There's.

In terms of a control arm I think we don't know this is kind of have to ultimately be discussed with the agency.

With regards to EUA again, that's sort of a fact.

Facts and circumstances on the ground at the time.

In terms of you know the eight.

Agents, who decides.

What gets our emergency use authorization in some instances as you've known they've given us they've pulled it back.

Depending upon.

You know the evolution of that.

Virus or.

And the severity right now.

You know there is a thought that EUA could.

Simply be available.

And the high risk patient populations, but needs to be confirmed ultimately obviously through discussions with the agency.

Great Super helpful. Thank you both very much.

Youre welcome.

Our next question coming from the line, obviously with Gellar with Roth Capital. Your line is open.

Hello, and welcome to the team.

That's terrific.

A few years. The first one is just about.

Your 235 per Gram relative to pack for Brett as we've been looking at the chemical Scott Salmon, which it's been wondering.

You know what you need to kind of optimize your molecule relative to Darren and then how do you expect these programs to be differentiated in the clinic.

Sure.

Yeah.

Okay.

Well.

Much as I could or much as I would love to we won't get into a chemical structures. So.

This evening.

But suffice it to say you know this is what we do.

Among the things we do it at all because it's just very good at.

Drug candidate optimization so it's.

<unk> that we know well we've done many times.

But many times on protease inhibitors and have ultimately.

To.

Got to market with two protease inhibitor so.

This process is no different.

It's been a very.

Strong drug discovery effort and now we're going to supplement that with a very strong development effort.

I'm sorry, the second part of your question.

I was just swinging differentiation.

So yeah, so allows them safety one.

Yeah sure I a lot of people can you know, it's very easy to make well I shouldn't you shouldn't trivialize it.

It's easy to make a really potent molecule, sometimes but having all the other drug candidate characteristics that you would like to have on top of that can often erode the potency gains that you have so getting everything.

Put together in one package is the art and the challenge here.

So we just spent a lot of time focused on.

DNP characteristics of the molecule and making sure that the molecule had really good oral absorption.

A really good half lives are very good trough drug concentrations, but very good.

Distribution into important target organs in this case lung tissue.

And so it was an iterative process working through lots of different molecules lots of different chemical classes, and then ultimately refining all the various attributes including lots of virology.

And to.

A single molecule to take forward.

Think.

So far the preclinical safety has been very good and then move into the clinic soon we'll have.

The clinical.

Correlates clubs up in terms of safety and importantly, a PK. So I think those are ways.

You can differentiate starting in June one, we certainly have differentiated already pre.

Pre clinically.

Yeah.

Thanks, and then the follow up here is just that another catalyst that is B program.

Everyone's been trying to figure out you know how with those translate to the high risk patient population and so it just kind of wanted to follow up with another question regarding at risk patient population do you think it'll be more difficult or easier to kind of show a treatment benefit I know you are doing the highway because of the more.

I guess about patient population, but in terms of translating that the data from the less.

C b in patients so that the more high risk patients, which patient population is that a more difficult multi show a benefit in.

That's a very good question Budd.

Really hard one to answer.

It's because they were so they're they're all.

Hmm.

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You've got.

You know you have kids that.

Now even from a <unk> standpoint kids are different and they're not just little adults. Then you have a slightly different clinical presentation.

And high risk elderly population, sometimes they have other comorbidities.

And that can be confounding the immune suppressive, obviously have very different things going on so you know to political three very.

Different patient populations.

Which.

It's going to be the hardest great.

Very hard to do that.

From where we sit today.

It is.

It's fairly easy to understand how each of those patient populations.

Benefited from an anti viral versus not getting one.

And that's in the end.

What we need to show and as long as we can show a good clinical benefit we.

It will have moved the ball down the field, where no one's done it.

Thanks, and then the last one he is a combo question. The first part is just about you know plans will have more detailed specifics about that.

Newmar virus program I think one of the things Mike about the pipeline initially with the multiple shots on goal and so I think people get your melon Shin sitting kind of understanding I you know where you are with your next development candidate and then the second part is for Paul can you talk a little bit about capital allocation.

Patients who might be dipping efforts, including early stage development efforts, and then whether or not.

The expenses associated with the Nash program have all fallen off thanks again.

Yes, so human meta Nemo.

As I said in my opening remarks programs looking very exciting.

We've made a lot of drug candidate to the Nantong and.

No we are.

We're taking it down two finalists to molecules right now for human medicine came out to remind some.

Some of you who don't remember the human melanoma.

Is.

Sort of the second leading cause.

Of of everything that RSV does and then basically the same patient population so.

We are you know the young.

The elderly high risk.

The immune compromised.

And so it's a it's a very nice complement to RSV. We got two candidates moving forward in RSV, obviously, human melanoma World and Covid of course, we will.

Really rounded out.

But from a.

Capital allocation perspective, we fund them as needed.

You know and it's all stage dependent they go through sometimes get into safety studies that becomes very expensive for the preclinical side of things and then you get into foods. One it's all chartered out basically in terms of how we're laying.

Laying out the pipeline evolution and the timing of all the things that we've got going on.

But that allocation changes.

Around a little bit what I will say is you are correct.

Sure.

The clinical trials in Nash.

We do have a.

The discovery program.

Quite interesting that will be presenting at easel.

At because it's just sort of the last phase of the.

The internal Nash activities.

So we.

You know really the focus there is now that we have two effects ours, where we've defined.

Doses for future combination that would ultimately.

Reside in and potential combinations down the road through.

Business development activities, but those would be activities that would be conducted by the partner.

Okay.

Yeah.

Our next.

And our next question coming from the line of Brian Lewis.

From SBA Securities. Your line is open.

Great afternoon. So a question on your new adult RSV study and could you talk a bit more about the rationale behind selecting high risk patients that had asthma chronic obstructive pulmonary disease or congestive heart failure over other possible comorbidities that could've conferred high risk and.

I know it's still in the works that are you considering doing anything to help balance enrollment across the subgroups in the future trial or are you thinking about other levers that you can pull here.

Sure why don't I ask.

Moderately to take that one on.

The other seven patient populations truths anymore.

So maybe just simply answering that you know one of the patient population that we are just finding that.

Hi, Elyse can be lifting severe progression as far as the disease. When you study that they need to make it up to me.

On guidance, but I'm, saying no from a clinical standpoint, so patients behind me.

It was funny as being age.

Angel more than 65 years old so they wouldn't be bountiful.

The next study for the highly skilled patient study and typically the one that of BT feel.

That I have congestive heart failure or asthma also candidate to be the progression to severe disease with RSV.

So it is important.

If you look at this patient population to better understand.

Once a year.

Treatment or you change the course of the progression of disease. So those are mainly the justification of why we are just finding out on those high risk patients this way.

Did I answer your question.

Yes, and I was curious if you would do anything to balance enrollment across the different subgroups.

There's no particular need just 25 within this group.

But you know they would be certainly you know once the steady and well.

For a complete you know as you know we don't really isn't it doesn't shrink said population we need to.

But theres no.

Q2 was 23.

And again I think Jay has mentioned earlier that you know we would give it a bit more color on the political things Ryan as we aren't getting close or even to disclose in this discussion with regulatory.

Got it and when the RSV a question for me. So do you have any updates on how recruitment is going and where Freddie RSV peds and RSV T. X studies have you noticed any seasonal trends are.

Unusual seasonal trends et cetera across your different sites.

Yeah. So.

Might've seen the RSV kind of spiked up and it spiked back Alright trail back down and so it's actually a very low rates.

Presently so I think you know like.

Like before we will be looking for spikes in the southern hemisphere, followed by ultimately spikes in the northern Hemisphere and.

In the fall and early months.

Okay, great. Thanks.

Youre welcome.

Thank you and I will now turn the call back over to Jennifer.

Yes.

Thank you everyone for joining us today, if you have any additional questions feel free to contact us by email or call the office.

Have a good night.

Ladies and gentlemen that doesn't go conference for today. Thank you for your participation you may now disconnect.

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