Q4 2022 Enanta Pharmaceuticals Inc Earnings Call
The conference will begin shortly to raise your hand during Q&A you can dial star one one.
[music].
Good afternoon, and welcome to <unk> Pharmaceuticals fiscal fourth quarter and full year ended September 30th 2022 financial results conference call.
At this time all participants are in a listen only mode there'll be a question and answer session at the end of the prepared remarks. Please be advised that this call is being recorded.
And I'd like to hand, 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 fourth quarter and full year 2022 financial results was issued this afternoon and is available on our website on the call today are Dr. Jay <unk>, President and Chief Executive Officer, Paul <unk>.
Allen, 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 of which involve certain assumptions and risks beyond our control that could cause our actual developments and results to differ.
Materially from those statements a description of these risks is in our most recent Form 10-Q and other periodic reports filed with the SEC Atlanta does not undertake any obligation to update any forward looking statements made during this call I'd now like to turn the call over to Dr. Jay <unk>, President and CEO Jay.
Thank you Jennifer and good afternoon, everyone.
We are leveraging our expertise in medicinal chemistry, virology and preclinical sciences to discover new compounds that can be developed into groundbreaking medicines.
Our fiscal fourth quarter as well as 2022 overall was a year of progress towards this effort with multiple ongoing and planned clinical studies across our pipeline. We are poised to execute on our vision to transform the lives of patients with curative therapies building.
Building on our prior success and hepatitis C.
Today I'll start by detailing our recent advances in the development of Edp three five our once daily orally dosed inhibitor of Corona virus three C. L protease.
Which is in clinical development for the treatment of COVID-19.
I will then comment on our RSV and human Metapneumovirus pipeline progress since our last call as well as our work in hepatitis B.
Starting with COVID-19, we were pleased with the recent advancement of Edp 305 into the next stage of clinical development with the initiation of sprint.
<unk> two clinical trial in COVID-19 patients.
Randomized double blind placebo controlled study will enroll approximately 200 non hospitalized.
<unk> patients with mild to moderate COVID-19, who are not at increased risk for developing severe disease.
Patients will receive 200 milligrams or 400 milligrams of Edp three to three five or placebo orally once daily with food for five days and will be followed for 28 days thereafter.
Patients will be eligible to participate if they have had symptoms for not more than five days and have not received a sars cov two vaccine.
In fact, it with Sars cov, two within 90 days of enrollment.
Primary objective of this study is safety and Tolerability and key secondary objectives include pharmacokinetics and multiple virological measures to guide our dose selection for subsequent trials.
And other studies of protease inhibitors, the viral load decline that's been similar between high in standard risk populations. Thus, we believe in rolling from a larger pool of standard risk patients will be a more efficient way to collect this information.
We are aiming to report results from sprint in the first half of 2023.
As previously reported data from the Phase one study of Edp 305 demonstrated it was generally safe and well tolerated up to 400 milligrams for seven days with strong exposure multiples over the EC 90, which is a measure of potency specifically it is the concentration of the drug that results in 90%.
Inhibition of viral replication in vitro.
Adverse events were generally mild and infrequent.
200 milligrams of Edp 305 taken once daily resulted in mean trough plasma levels at steady state that were three fold and seven fold over the plasma protein adjusted <unk> 90 for the Alpha variant and Omicron variant respectively.
<unk> 400 milligrams resulted in levels that were six fold in 13 fold over the plasma protein adjusted <unk> 90 for the respective variance importantly, these target exposure multiples were achieved without the need for return of your boosting and its associated drug drug interactions.
Based on preclinical studies Edp three five is projected to have four times higher drug levels in lung tissue compared to plasma, which would be expected to drive up to a 28 fold multiple for the omicron variant at even the 200 milligram human dose.
As COVID-19 persists, new variance of rise that can circumvent immunity from vaccination previous infection or a monoclonal antibody treatments. We are committed to developing edp three five as a convenient and easily prescribed antiviral, which continues to show strong activity against all <unk>.
With 19 variance tested to date.
Beyond the COVID-19, we are also encouraged by the progress we have made in our respiratory syncytial virus or.
RSV program.
RSV is a virus that represents a significant unmet need as it can result in a severe respiratory infection and is associated with significant morbidity and mortality in children, the elderly and other high risk populations, while RSV was mitigated for some time due to social distancing measures during the pandemic.
<unk> infections are now on the rise in the U S and the need for a treatment remains high as there are no targeted therapeutics currently available.
We are pursuing a robust RSV program, which includes Edp 938, the most advanced and protein inhibitor in clinical development today as well as Edp 323, a novel oral therapeutic targeting the RSV L protein RNA polymerase.
We are currently evaluating edp 938, and in high risk populations, including pediatric patients adult hematopoietic cell transplant recipients and other high risk adults all of which have a significant unmet need.
Last month, we initiated RSV HR, a phase II B study in adults with acute RSV infection, who are at high risk of complications, including those over 65 years of age and are those with congestive heart failure COPD or asthma.
<unk> is a randomized double blind placebo controlled multicenter global study designed to evaluate the effect of Edp 938, compared with placebo on the progression of RSV infection.
Approximately 180 patients will be treated with 800 milligrams of Edp 938, or placebo for five days and then evaluated over the next 28 days.
The primary endpoint for this study is time to resolution of RSV lower respiratory tract disease, sometimes through day 33.
Our other studies of Edp 938, namely RSV Peds, a phase III study in pediatric RSV patients and RSV.
It's a phase <unk> study in adult hematopoietic cell transplant recipients with RSV are ongoing.
We believe Edp 938 has the potential to deliver a potent oral antiviral treatment for all populations at high risk from RSV infection, and we will continue to monitor the RSV trends during the northern hemisphere season to enable us to better evaluate timing for data.
This quarter. We also began dosing in our phase one randomized double blind placebo controlled study of Edp 323 in healthy adult subjects.
Study will evaluate the safety tolerability and pharmacokinetics of orally administered single and multiple doses of Edp 323, our novel oral therapeutic targeting the RSV L protein RNA polymerase.
Edp 323 supported by promising preclinical data presented this quarter at the 12th International RSV Symposium.
Which showed that Edp 323 inhibited preliminary this activity in vitro and also inhibited the virus induced cytopathic effect of both RSV, a and RSV b strains.
In a rodent RSV infection model treatment with Edp 323 was associated with improved lung histopathology and dose dependent reductions in pro inflammatory cytokines.
We believe Edp 323 could serve as a standalone treatment or may be used in combination with other agents such as edp 938, potentially broadening the treatment window or addressable patient populations for RSV.
Moving onto our respiratory discovery program in human Metapneumovirus or H, MPV, which is a virus that is similar to RSV and impacts several vulnerable populations, including the elderly adults with underlying pulmonary disease and those who are immune compromised. This.
Quarter, we presented preclinical data at the <unk> annual RSV symposium, highlighting advancements in <unk> PV detection quantification and growth methods for the generation of an improved tool kit for the in vitro characterization of multiple HPV strains.
Our goal is to select a development candidate for <unk> next year.
Turning to hepatitis B, our goal remains to develop a functional cure for chronic HBV patients, we continue to evaluate internal and external opportunities for additional candidates to develop in combination with Edp 514, as we believe the ultimate cure for this infection will involve combination therapy.
Our commitment is based on the continued high unmet need for this disease, which is a global public health threat and the world's most common serious liver infection, making it the primary cause of liver cancer also known as hepatic cellular <unk> carcinoma or HCC, the second leading cause of cancer.
Our deaths in the world.
We believe that a core inhibitor such as Edp 514, it could ultimately be an integral component of our successful combination regimen.
Finally, I'd like to wrap up by highlighting our near term clinical milestones for the first half of next year.
We look to progress sprint as quickly as we can through phase two and to report data in the first half of 2023.
Further we expect to have data from our phase one study of Edp 323, RSV L inhibitor also in the first half of 2023.
With that I'll turn the call over to Paul to discuss our financials Paul.
Thank you Jay I would like to remind everyone that financial reports on a September 30 fiscal year schedule.
Today, we are reporting results for our fourth quarter and full year ended September 32022.
For the quarter total revenue was $20 3 million and consisted of royalty revenue earned on <unk> Global Maverick net product sales.
This compares to total revenue was $23 6 million for the same period in 2021.
The decrease compared to the prior year was due to a decline in abbvie sales of Maverick.
Royalty revenue was calculated on 50% of Maverick sales at a royalty rate for the quarter of approximately 10% after adjustments for certain contractual discounts rebates and set us which are now approximately 2% of these total reported HCV product sales.
You can review our royalty tier schedule in our 2021 Form 10-K.
Moving on to our expenses for the three months ended September 32020 to research and development expenses totaled $34 8 million compared to $48 9 million for the same period in 2021.
The decrease was primarily due to the timing and scope of the company's clinical trials.
General and administrative expense for the quarter was $12 6 million compared to $8 4 million for the same period in 2021.
The increase was due to additional headcount and stock compensation expense.
<unk> recorded an income tax expense of point <unk> 1 million for the three months ended September 32022, and an income tax benefit of <unk> 4 million for the 12 months ended September 32022, which are due primarily to the release of state tax reserves.
NASA recorded an income tax benefit of $8 8 million and $28 6 million for the three and 12 months ended September 32021, respectively. Due primarily to our federal net loss carry back available in fiscal 2021 under the cares Act of 2020.
And that is still due a refund of $28 7 million for the tax losses carried back in 2021 to offset taxable income in prior years.
Net loss for the three months ended September 32022 was $26 3 million or a loss of $1 27 per diluted common share compared to a net loss of $24 6 million or a loss of $1 22 per diluted common share for the corresponding period in 2021.
And at the ended the quarter with approximately $278 5 million in cash and marketable securities.
We expect that our current cash cash equivalents and short term and long term marketable securities as well as our ongoing royalty revenue will continue to be sufficient to meet the anticipated cash requirements of our existing business and development programs into the fourth quarter of our fiscal 2024.
Regarding guidance for fiscal 2023, we expect our research and development expense to be between 210 million to $230 million.
General and administrative expense to be between 46 million to $52 million.
Further financial details are included in our press release and will be available in our annual report on Form 10-K when filed.
I'd now like to turn the call back to the operator and open up the lines for questions.
Operator.
Thank you Sir.
As a reminder to ask a question you will need to press star one one.
On your telephone.
Please standby, while we compile the Q&A roster.
And I show our first question.
Comes from the line of Brian Abrahams from RBC capital markets. Please go ahead.
Hey, good afternoon.
Thanks, so much for taking my questions. Congrats on the continued progress across all the programs.
Maybe just starting on the on the Covid on the 235 study the sprint program I'm.
I'm wondering if you could maybe talk a little bit more about some of the key biological measures that youre going to be looking at.
In order to help guide dose selection going forward and I guess.
How much are you going to be also looking at it.
Symptoms as well.
Is there I guess, how might you account for the potential for.
Patient to patient variability just based on intrinsic immune differences vaccination status prior exposure status in terms of elimination of virus in order to.
Sure you have kind of a standardized look at.
At the different doses relative to placebo.
Sure.
So thanks, Brian for the question.
In terms of looking at the.
Quote standardized population I think we're trying to control at least for some of the variables that we can one of them is vaccination.
Bye now.
So many people are back.
Had a vaccine in the last.
Three months.
And the same is true with Covid.
Within the last 90 days so.
Thats immunity.
Tends to wane and.
Youre not taking fresh COVID-19 patients or people that have been fractionally bag. So that's one of the factors.
And then going back to.
The study design.
We're focusing.
Primarily for <unk>.
Safety and Tolerability as a primary endpoint.
And then on a.
Gather enough information.
As possible in the shortest smallest possible study that we could conduct that would be phase three enabling we're going to look at other.
Parameters.
Barbara logically.
The things the things that you can measure.
Two.
Predominantly be viral load.
Again, as you know COVID-19 drugs.
General.
So usually profound changes on viral loads in fact.
Yes.
Ram desk severe doesn't show any change on viral load so protease inhibitors have shown.
Small sort of modest changes.
Viral load reduction so we will certainly.
And looking at that we'll look at AUC.
Time to undetectable things things like that.
Regarding.
Clinical symptoms on outcomes again.
Small study like this.
Our exploratory than anything I think in a small study size and the way youre not really and then thats patient population particular, youre not really going to be expecting to see too much in the way of.
But we'll be looking for.
We will definitely be looking for trends and things that we can possibly measure and focus on as it relates to later stage studies.
So hopefully putting all that together.
Small.
Study.
We will have enough information from there to select our dose between the 200 milligram dose and the 400 milligram dose and then go forward onto the next steps.
Got it no that makes a lot of sense and then we've obviously seen a wave of RSV.
Across the country and the globe of late and to what extent have you been able to I guess take advantage of that with regards to patient enrollment in the ongoing 938 studies and are there any are there any changes or adjustments you might make too.
Site Onboarding.
<unk> of sites.
Overall protocols to be able to optimize enrollment in light of the spike we're seeing.
Yes so.
Well as you know.
We have three high risk patient trials going on we have a pediatric study.
And we haven't been immune suppressed patient population who are bone.
Bone marrow transplant recipients and then the third study, which we just announced and just got up.
The high risk adult studies. So these are adults, who are 65 years and older and <unk> had some other things going on either.
COPD congestive heart failure or things like that so things that are putting putting them at high risk.
And so as.
So you can know.
In the past there was definitely a drought and RSP during the heart of the pandemic.
And it's clear that some of Thats come unwound now is that patients.
Various various people's communities.
Waned over the period of time, there's also seems to be a very early season of RSV. This year.
Let's see so at the very least it early.
Early.
We'll see how severe it is over time and how protracted that is over time.
We need to.
Basically watch the northern hemisphere.
Season, which is which is definitely cranking up and then.
See where we stand with.
With all of our sites around the globe.
On these various studies at the end of the North American seats or Northern Hemisphere season Tonight, I should say and then we will have a better sense.
Where we stand in each of those studies.
Got it I'll hop back in the queue. Thanks again.
Youre welcome.
Thank you.
One moment, while we compile it our next question.
Okay.
And I show. Our next question comes from the line of Yasmin Rahimi from Piper Sandler. Please go ahead.
Okay.
Good afternoon, Kim Congrats on all up to date and your thoughtful remarks as usual.
I guess the question for you Tim.
Mike fast forward to sprint data coming out in the first half.
2023, thank you for telling us what the bar and what do you want to see in this study, but what would the next steps be.
No.
Where are we in terms of regulatory approval.
Covid therapeutics, what's the bar so just give us some framework on what our elements of the next steps post spring that are determined in butter may be unknown.
That would be really helpful. And then I have a quick follow up.
Sure so.
Sprint is a phase II study again.
We're aiming to have it be phase three enabling and then also.
Dose selecting trial that we would.
Be conducting so the next step would be no phase III.
The specifics of that trial design.
We will continue to.
Plan internally and also have interactions with the agency with regards to be exact.
Trial design so.
It's going to be some more interactions along the way hopefully with the and.
Having good data in our hands.
During those discussions so a little bit early to focus on what that design will look like.
Again, we're hoping to.
To wrap up the study as quickly as we can have data in the first half.
And then aim for phase three in the back half of the year.
Thank you Jay and then <unk> question about <unk>.
<unk> three.
It seems after we see the phase one data is just strategy like what is the type of data that you would want to see that would support moving it forward in monotherapy and combination. So maybe if you could walk us through what the data scenarios could be.
Both the optionality that could be helpful for us.
I'll jump back into the queue.
As you know.
First molecule in the clinic at 93 eight.
A direct acting anti viral so its a replication inhibitor.
In contrast to <unk>.
Other approaches that have been tried in the past.
And.
In the press it take us in terms of entry inhibitor. So we were focusing on.
Replication inhibitors, we again, we believe that that's the best way to shut down.
And active replicating virus in a patient who is presenting.
And so.
So to that end, we didn't want to just have one such class.
And we're very committed to RSV overtime, and we want to have multiple different approaches overtime someday you might think about combining them again theres no reason, our preorder you to believe that.
Overwhelming majority of patients you would need to have a combination strategy, but we would like to have that possibility for a few different reasons that I can articulate in just a second but three Q3 is another.
Other replication inhibitor it goes after.
The preliminaries.
<unk>.
And what we do in any of our candidate discovery programs. We're always focused on finding very potent molecule with good safety and good pharmacokinetics and good bio distribution.
So $3 three checks all of those boxes pre clinically and so phase one.
As is our usual.
Yeah.
Is it really just hopefully recapitulated in all of those kinds of bits of data.
Yeah, no human phase one setting so it will be looking for of course good safety.
We'll be looking for good PK.
All of our again preclinical predictions support that it should have good oral PK once daily dosing something we also are always aiming for here.
And then.
Yes.
We know that the molecule has extraordinarily good virology had some very very potent picomolar inhibitor of this.
Polymer so.
Pre clinically we.
Believes.
It's a good standalone molecule.
All right.
I'd say.
Its potentially a good combination partner down the road again thinking about different patient populations months.
That might need an extra little.
In terms of drug pressure on the virus, maybe and highly immune suppressed patients for example.
Or <unk>, just really none in.
More normal pace.
Patient.
Bye.
Maybe able to reach a little bit later in the stage of infection by using two agents rather than one and translating that into.
Patient value.
It's potentially widening the treatment window that you might have to come after.
Hey.
Person.
They present with the infection so.
However, many days of a window treatment window.
Might have with one drug maybe two drugs would just widen up that opportunity.
We're increasing the addressable patient population. So these are the kinds of things that we're looking for again, it's always better to have.
Multiple different approaches on any area or any disease indication that we feel very strongly about and then as you know we've been championing RSV for us.
Quite a number of years, starting with the earliest discovery efforts in a long time ago.
<unk>.
Alright. Thank.
No.
The pandemic.
<unk> is very high on human respiratory viral treatments.
And yes, we're very pleased to have a second molecule now in the clinic. So next steps we will get the phase one data we will look at it and then we will think about.
Our next steps.
Once we have that data in hand, then you could go a couple of different routes you could go into a challenge study or you could go.
And to the patient population.
We're obviously thinking about that sort of thing right now.
We will have more details.
<unk>.
Thank you.
And I show. Our next question comes from the line of Brian <unk> from Baird. Please go ahead.
Hey, good afternoon, everyone. Thanks for taking my questions I had a few quick ones on the 83 five sprint study I guess to start since you're at 7% and 13 <unk> for the Omicron variants are you expecting any dose response on viral load and it seems like you'd be overkill in terms of shutting down the virus I'm just wondering what you are.
Sure.
If anything you expect to see in terms of differences between the dose and then I noticed on clinical trials do you have a couple of different.
Measures of viral load can you just discuss how you are measuring.
RNA viral load versus infectious viral load.
And then finally, how do you think of the number of days of symptoms Youre enrolling patients I think five days is where youre cutting off does that too many to sort of catch a separation of the curves compared to placebo just trying to think through the time course of viral load evolutionary and if theres a risk that you're capturing a lot of patients in the decline phase.
Yes.
Sure.
Maybe I'll, let Terry comment on.
The.
The viral read outs.
What I would say it is on the 204 hundred.
Hello, Graham doses, we may or may not see we may see.
Well, there's all kinds of tough.
Right when you look at two doses, but.
It's possible that given the strong multiples we have that either.
Those two doses does what we needed to do.
Or there is still a possible that you might see some dose range or dose response in something.
These are the two reasonable doses that we that we chose to evaluate us and to exactly why we're running the study just to see if we can.
Differentiate is there any differentiating.
To be done here.
The five day piece.
<unk> and Pfizer have shown good viral load drop in various patient populations with a five day treatment window.
You can obviously stratify.
People, depending upon what their actual window was.
It won't be more than five days so.
So that's what.
What I would say about that and then Terry do you want to comment on the.
The viral readouts.
Sure Jay Hi, This is Tara Brian So we'll be looking at the viral load the RNA and that'll be done by PCR.
And that's primarily what a lot of other.
Companies have read out on their on their programs will also be looking at infectious virus and that'll be done through culture. So this is actually looking at.
Live in Texas virus that is still in the samples.
So we'll be looking at both of those readouts.
And those are both just nasal swabs.
Correct.
Great. Thank you.
Thank you.
Thank you.
One moment, while we compile our next question.
And our next question comes from the line of Lisa <unk> from Evercore ISI. Please go ahead.
Yeah, I think most of my questions have been answered, but maybe just on.
The Covid study that you announced can you explain.
Sort of I guess, the overall goal here and do you.
What are you trying to learn from this study and in terms of.
Enrolling the more kind of lower risk patients are you concerned at all that you have a similar outcome.
Than you than you did in RSV, where you kind of don't see any necessary.
Kind of.
Separation in terms of resolution of symptoms or there are any outcomes, just given that youre not focusing our enrichment study for sort of that higher risk group. So could you comment on.
What your objectives are the study in light of that.
So the focus there on the low risk patient population. Thanks.
Sure. Thanks for the question Lisa So one of the key reads that we'll be watching for on the <unk> side of the table.
Viral load and one of the things that we know is standard risk patients and high risk patients have very similar viral loads what happens after that to those various patient populations dippers.
But.
This is why if you are looking at sometimes or outcomes. Some of those things those would be harder to measure.
And the so called standard risk patient population so.
But again when bringing it back to looking at the virus.
Trying to figure out which dose youre going to use.
Safety and Tolerability.
Turning to things that you should be able to do quite adequately.
In this in this patient population and then once we've got our dose.
Based on all those parameters again going into phase III. You can you can broaden out and look at many different outcomes and we will have obviously larger powered.
Studies too.
Two.
Look at those kinds of things so.
Yeah, So pfizer's prices shown.
But it's the viral loads are very similar standard risk or high risk.
Yeah.
You saw viral load effects and that standard risk calculation.
Thank you.
Youre welcome.
Thank you.
One moment, while we compile our next question.
And our next question comes from the line of Eric Joseph from JP Morgan. Please go ahead.
Hey, good evening, thanks for taking the questions.
Just thinking about this phenomenon of viral rebound scene with Pfizer's tactful good.
I'm, just wondering sort of what your understanding is behind that phenomenon and whether sprint offers the opportunity kind of looking at similar.
But I'm gonna at least.
That's for it in the post treatment follow up period are you looking at.
Viral load beyond.
Well, let's say two weeks.
And then as it relates to RSV and.
The potential for.
Kind of thinking through potential combinations with 938 and 323.
I guess practically speaking one would be sort of the first opportunity to really explore that potential is there a useful too.
Preclinical model that would kind of inform the potential for additive benefit through combinations. Thanks.
Yes so.
Two good questions. So the rebound thing.
Interesting I mean, it does seem to be.
Certainly a real phenomenon, although you can get rebound even in people, who don't take back some of it is just part of the natural.
Of course in patient sample resolved do you think you're better than your rebound, but that that phenomenon has definitely been observed.
And <unk> treated patients to date.
And part of their.
The thing that we've been wondering about is why is that clearly there must be some little pocket of virus, that's not fully taken care of.
Ideally you want to beat the virus down to a low enough level whenever tissue you need to beat it down in and then get it down to sufficiently low levels that the immune system can kind of come in in March things up and help you out.
So our speculation is that among the possibilities there could be a little reservoir, a buyer is hiding somewhere and that you need to further extinguish it and so do you do that by treating for longer days.
Thats, one parameter that will be sorted out over time, but the other.
Intriguing possibility is one that potentially edp 305 could have an advantage on and that is.
Higher tissue uptake in terms of.
Uptake into key target organs, such as lung tissue.
We've demonstrated at least pre clinically.
Drug concentration.
Out of the plasma and ended the tissue.
And at least in lung tissue.
<unk> hundred one concentration so that wasn't observed.
And the.
Other protease inhibitor.
Out there and so.
We've looked not only at lung tissue, but we've looked at many other tissues as well that are potential reservoirs for virus.
Some of our concentration goes up even higher than that so we'll have more data on that topic coming up this year, but.
We're hoping that 235, owing to its really good potency really good.
Drug exposures after QD administration.
Brian Scorning mentioned, we've got very nice multiples at either of our doses against <unk> and then you add on top of that the potential of having good tissue uptake where the virus might be.
Hiding out in a little harder to treat so we're hoping that that could all add up to having some impact on rebound and we will certainly be looking at that and our.
In our study because we'll be dosing for five days and then we have a 28 day.
A follow up so we'll have a chance to watch these people out to date 33.
So that's.
So that's <unk>.
Pregame.
Our hypothesis that we'll be testing the other.
<unk>.
<unk> that you had I think it was about RSV.
We have 93, eight obviously advancing in three high risk patient trials right now.
323.
Proceeding nicely in a phase one study will it'll be ready too.
To look at.
And virally infected people.
Hopefully soon enough and.
You asked I think the specific question on how could you look at that as a combination and one of the possibilities.
It could be thought about doing that in a challenge study we already have.
Fantastic Challenge study data with 93 eight.
One could do a challenge study with <unk> three and also look at the combination of the two.
See what parameters what might be able to improve so you ask what would be the earliest.
Way that you could look at that that is probably the earliest quickest way to get.
Interesting data about combinations.
Okay.
Okay, great Great I appreciate you taking my questions. Thanks.
Thank you.
Thank you and I show. Our next question comes from the line of Roanna Ruiz from <unk> Securities. Please go ahead.
Great. Thanks, Good afternoon, everyone. So a quick question on the sprint trial I was curious on the clinical symptoms secondary analysis, specifically are you going to focus in on a key set of symptoms similar to what we saw with <unk> late.
Late stage trial data or will you plan to be a bit more broad in your exploration of different symptoms of COVID-19.
Terry you want to handle that.
Sure Hi, Atlanta, it's Tara.
Well, we'll certainly look at all the symptoms in our trial and then we will have the ability to do.
<unk> is a specific subset so to your point looking at those five contend that he was able to show an effect onto will we be able to do both and we will also be able to learn.
Way with the <unk>.
Comprehensive dataset, how best to move until later study as well.
Got it makes sense.
Yes that helps and four I wanted to ask about 93 eight for the RSV HR study.
Do you expect to see a good balance of different high risk patients being enrolled like across COPD, asthma et cetera, and I'm not sure. If I missed this but do you have any input on what you think the sequence of readouts might be between your different RSV trials like RSV Peds, RSV, TX and Rx.
The HR.
Yes, so the readouts on those we'll just need.
More data through.
Steve.
Uh huh.
RSV to really tell.
Such different patient populations.
Peds here.
Just three very different patient populations and so.
I think we just need more information to know what will pull pull ahead.
With regards to your question about are we.
Worried about two.
Too much enrichment of one patient population or another is that what you asked I mean for example, we are capping.
Those older.
Age 65.
And as at 20%.
This will help enrich for the more high risk COPD congestive heart failure patients. So it won't be just completely filled up with asthmatic.
Is that.
What youre getting at in your question that helpful.
Yes, that's helpful. Thanks, a lot.
Got it thank you.
Thank you and I show. Our next question comes from the line of Jay Olson from Oppenheimer. Please go ahead.
Oh, Hey, congrats on the progress and thanks for taking the questions.
At a very high level, how long do you anticipate it will take to get regulatory approval for 235. So are we talking about a couple of years or is it going to be several years and how will COVID-19 treatment dynamics evolve over that timeframe and then what are your latest thoughts about a potential part.
<unk> for the development and commercialization of two or three fives, and then I had a follow up question on five months or so I could please thank you.
Sure so.
There are.
Some good questions actually the future of the pandemic.
And.
How that will play out over time.
One that's continued the vacs.
The vaccine.
Clearly were at least for now we seem to be getting into.
And then <unk> phase.
Maybe we're at the.
At the beginning of the end.
The pandemic phase.
Shifting toward endemic even thats going to.
Probably several years away before it's truly.
The endemic phase.
I think the.
Trends.
In terms of regulatory pathway.
That's available I think that's also going to be something that will be looked at carefully as we progress through <unk>.
Development, there's different assumptions, depending upon what variance that might emerge.
But right now our focus is on finishing up sprint and having data in the first half moving into a phase III study.
The back half of the year.
And.
Conducting that as expeditiously as we can I think.
EUA is still an option as far as we are aware of at least in certain patient populations and so.
But will that be the case later.
You really need to let it play out.
In terms of the timing of the program juxtapose the backdrop.
Uh huh.
The environment that's going on.
One of the interesting things about the variances there.
<unk>.
All the time it was not that long ago that we were talking about <unk> four and <unk> five.
Within the last few weeks.
<unk> be Q1, and one one <unk> have all but taken over.
And mercifully.
<unk>.
Yeah.
They don't seem to be as.
As lethal as certainly some of the earlier variance, which is good but these things can switch all around so.
We'll get be watching the landscape, that's going to dictate a lot of power.
<unk> phase III.
Enrolls in what patient population, what regulatory pathways that are available to us at that time.
There is still an unmet huge unmet need for <unk>.
Antivirals.
The vaccination rates have probably stabilized.
To a great degree.
Theres some vaccination fatigue out there the antibody is also.
Continue to be losing efficacy.
And many of them as you know have dropped off in terms of being effective so far.
And there really aren't that many therapeutics.
Our mechanism based and well understood that are going forward. So this is a really large market opportunity it's going to be one.
Pretty much going forward.
And one in which there arent.
Yeah, I would submit that the.
Optimal therapies are not yet approved we look at two or three 5% cycling a very strong profile in that regard.
So.
That part.
I think the need for therapeutics will will be very high.
Extraordinarily well too as you know with our respiratory portfolio not just in one program, but obviously the breadth of all the RSV stuff that just have been talking about this evening.
As well as human meta Nuno again human meta pneumo.
Something youre going to continue to hear more and more about as these things are.
Our being under the spotlight increasingly.
Partnering is still the plan again.
This is.
Going after a pandemic virus on a global scale.
It was bigger than we are and it's our.
Gold to really maximize 235 globally to the to.
The greatest patient base, we could possibly sir.
Harder to achieve that.
We will be seeking a.
Global partner.
And our efforts here.
Great. Thank you that's Super helpful. And then on 504 can you talk about what sort of mechanisms do you plan to combine with 514 and will it be an existing anti viral treatment or is something in clinical or preclinical development and will it be something in your own pipeline or something external.
What are your latest thoughts on seeking a partner for 501 four.
Yeah, so the right combination.
Hep B as is.
The slow story to play out in terms of combination therapy, I mean combination and we're working on Hep C.
Combination.
<unk> therapy, even though all combination therapeutics, a while combination therapy was fairly.
Straightforward by comparison and as much as the trials were much shorter you had things that you can measure it very quickly you had profound changes in viral loads.
It seemed to correlate with getting too.
Basically.
Our cure.
And all of those rules are slightly different in HBV and so I think we're still at the stage, where the right combo.
Is not yet known yet.
We noted that nukes and core inhibitors do useful things in terms of.
Producing viral load.
Not only the DNA that nukes do well, but we can also with the core inhibitor reduce DNA and RNA.
So I think we're going to need something that will adequately address the S antigen reduction component of this.
Might you need an immune modulator in the mix I mean, these are all things that.
Other people are starting to do combinations on.
Data readouts on.
But it.
It is not.
Yes.
It's not perfectly clear yet what that best asset class.
Would be and so.
We're being a little bit patient here.
We're thinking about doing a little bit internally and where.
Looking externally as well.
And ultimately.
Cool the right assets I E.
That will be able to do that.
At some point to really get back on the.
The Triple combination horse.
We really want to be on but meantime.
Yes.
The.
The.
Spend on clinical trials.
Not going to happen until were clear on that.
Okay understood helpful. Okay. That's super helpful. Thanks for all the color I appreciate you taking the questions. Thank you Jay.
Welcome.
Thank you.
As a reminder to ask a question you will need to press star one one on your telephone.
And I show. Our next question comes from the line of Roy Buchanan from JMP Securities. Please go ahead.
Hey, Thanks for taking my question I had a follow up on the 235 comment around.
I'm around the higher tissue uptake Jay you said youre going to have more data on that topic. This year or is that going to be a publication.
Our meeting presentation, and then kind of Relatedly for 938, any near term plans to publish the RSVP results.
So the RSVP results.
I'm not sure what the timing is on that quite perfectly honest.
I'm not sure what that timing is.
It's Hudson.
It's an important study to have conducted that is not the most important thing we're doing right now in terms of execution.
The the.
Three five data.
<unk> referred to and tissue distribution as you know some of that's been out there.
Other abstracts.
Are being written and submitted so.
Stay tuned on that front, we'll just.
We will.
Report once we.
Been accepted.
So that's confirmed.
Yeah.
Okay, but we will see that data before the end of this year.
Before the end of 'twenty two.
Yes.
That's what I heard you say.
No.
I don't believe I said that if I did I didn't mean it.
Let's say that I'm not sure where youre talking about are you talking about two to three five tissue uptake data that way.
Yes.
Not.
Not anymore. This.
This year, Okay fair enough all right and then the.
Maybe you kind of answered this with the partnering question, but how are you thinking about funding the phase III for 235.
<unk> guidance for R&D is going up quite a bit are you does that bacon, starting a phase III for 235, possibly startup for RSV phase III.
Yes so.
The.
The guidance is our.
Fiscal year.
Guidance that will go out through the quarter ending 930.
And so again, we're aiming to.
To have.
Sprint data in the first calendar half.
And so any.
Any phase III I mean, we've been doing preparations for phase III for quite some time, the CMC drug supply all.
All the rest.
Till the last minute. So we've been if you will incurring certain.
Phase III related costs.
Right now.
And we would expect those too.
To continue during the year.
Up through the quarter of 930 and those are in.
Included in that.
And that number.
Okay, great. Thank you.
So it's a conservative thing.
If there were a partnering change then obviously that changes bunches of things but.
But anyway, so conservatively, we've modeled it that way.
Thank you.
I'm showing no further questions in the queue. So this concludes our Q&A session. At this time I would like to turn the conference back over to Jennifer Viera for closing remarks.
Thank you everyone for joining us today, if you have additional questions. Please feel free to contact us by email or call. The office of a great evening.
Thank you. This concludes the conference you may now disconnect.
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