Good afternoon and welcome to Enanta Pharmaceuticals fiscal fourth quarter and year-end 2020, financial results call. At this time, all participants are in a listen-only mode. There 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, Senior Director, 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 2020 year-end financial results was issued this afternoon and is available on our website. On the call today is, Dr.

Jay Luly President and Chief Executive Officer; Paul Mellett, our Chief Financial Officer and other members of Enanta’s 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 development 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. Enanta 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 Luly, President and CEO.

Jay?.

ARGON-2 our Phase 2B study evaluating our first FSR agonist EDP-305 in subjects with liver biopsy proven Nash and a first in human study of EDP-297, a highly potent and targeted FSR agonist. But is there a follow-on FSR candidate.

As we move forward towards the remainder of 2020 and beginning of 2021? We look forward to initiating to new phase two trials for our program in respiratory syncytial virus, or RSV. Now let’s look at that portfolio programs in a bit more detail.

I'll begin with our virology focused programs, more specifically our respiratory virus programs, RSV, hMPV, and IA SARS-CoV-2. I'll start with RSV, where we are developing EDP-938 a potent nonphysician inhibitor of RSVa and RSVb.

RSV is a severe respiratory infection associated with significant morbidity and mortality in infants, the elderly and immunocompromised adults and a condition for which there is currently no safe and effective therapy.

In an average year in the U.S., RSV infection lead to around two million outpatient visits among children younger than five years old and hospitalizations of more than 57,000 children under age five and about 177,000 older adults.

Our phase 2b, double blind placebo-controlled study of EDP-938 will be designed to enroll approximately 70 subjects up to the age of 75 years, randomized to receive either 800 milligrams of EDP-938 or placebo for five days.

Starting here in the Southern Hemisphere, recruitment in that study has been affected by the ongoing COVID-19 pandemic and related shutdowns and social distancing measures which will reduce some incidence of flu and RSV.

So as placebo-controlled we've previously said, we are hopeful that the 2021 Northern Hemisphere, our species will allow us to finish enrollment in RSVP, but that will be dependent on RSV being as prevalent as in a normal season. To that end, we are reactivating close to 50 of our existing RSP. clinical sites in North America.

These sites are prepared with our PCR machines to diagnose patients are RSV and to rule out flu and COVID:19 in the same day, which should make enrollment as efficient as possible.

In addition, we're working to set up about an equal number of sites in six different European countries by year end and are also planning to add sites in the Asia Pacific territories in 2021.

As we know, COVID-19 is unpredictable, and the rate of enrollment in this trial will continue to depend on the prevalence of RSV infections and the precautions that people are taking for COVID-19 as the winter progresses in the northern hemisphere.

Considering that respiratory viruses often have hotspot, we are prepared with many geographically dispersed sites to identify and enroll as many patients as possible in this RSV season. Assuming we can complete enrollment in the second quarter of 2021, our goal remains to record data in the third quarter of 2021.

We also plan to initiate two additional Phase 2 studies with EDP-938. One, an adult transplant patient by the end of 2020 and another an pediatric patient\ in the first quarter of 2021.

The adult transplant study named RSV-TX with the Phase 2b randomized, double-blind placebo-controlled study to evaluate the effect of EDP-938 in adult hematopoietic cell transplant recipient, an acute RSV infection of the upper respiratory tract.

The pediatric trial, named RSVP will be a Phase 2 randomized double-blind placebo dose ranging study to evaluate EDP-938 regimens in hospitalized or non-hospitalized infants and children aged twenty 28 days to 24 months, who test positive for RSV based on an approved diagnostic assay.

Our goals for both of these studies to enroll during 2021 and 2022, subject to the potential impact of COVID-19 on the incidence of RSV infections and activities at trial sites.

Turning to our other two respiratory virus treatments and development, hMPV HBV a virus that causes respiratory infection or something simple similar to RSV and SARS-CoV-2, we have discovered several potent molecules.

For SARS-CoV-2 we’re leveraging our expertise in direct acting antiviral mechanisms to discover new compounds, to treat COVID-19 using a combination of drugs and target screen and drug design. The advantage of this discovery approach is that you can make potent purpose-built inhibitors against multiple different targets.

While we are encouraged that the vaccine could be available soon, we still see a need for an oral treatment for those in various patient population who are nonetheless infected with COVID-19. Regarding HBVhMPV, since announcing our new drug discovery efforts in January, we've been optimizing nanomolar inhibitor release against those viruses.

We are hoping to finalize a clinical candidate selection for each program next year. Let's move on to our hepatitis B program with EDP-514, our lead core inhibitor currently being tested in chronic HBV patients who are NUC-suppressed and end by remaking HBV patients.

In February, we announced positive results from Part one of the Phase 1a/1b clinical study of EDP-514 in healthy subjects, which allowed us to initiate Part 2 in in chronic NUC-suppressed HBV patients.

These encouraging data which highlighted positive safety and tolerability, as well as pharmacokinetics, suitable for once daily dosing, were presented in a poster presentation in August at the Digital International Liver Conference sponsored by the European Association for the Study of Liver or EASL.

Part two of the Phase 1a/1b study which is now ongoing, is designed to evaluate the safety, tolerability, pharmacokinetics and any viral activity of orally administered multiple ascending doses of EDP-514 versus placebo. And up to 24 randomized NUC-suppressed patients over a 28-day period.

Barring any further significant COVID-19 disruptions, we plan to have preliminary data on part two in the second quarter of 2021. Also, on our HBV program in July, we initiated a Phase 1b clinical trial in viremic HBV patients.

This randomized, double blind, placebo-controlled Phase 1b study in viremic chronic HBV patients not currently on therapy has a similar design to the one in NUC-suppressed suppressed HBV patients who plan to enroll twenty-four subjects at our clinical trial sites in Hong Kong and Taiwan, which are both areas with large unmet need for HBV treatment.

We expect preliminary data from this trial in the second quarter of 2021. And finally, we continue our HBV efforts in search of a novel oral agent against a different HBV mechanism that could be combined with EDP-514 in a nuc to create an all oral triple regimen. Progress against that has been strong this year.

We'll have further details around this new program and our oral HBV triple strategy early next year. Shifting gears to our work in nonviable liver disease, we are currently focused on Nash, where we are conducting clinical trials on EDP-305, our first FXR agonist.

Based on data from Argon 1, which was highlighted in an oral presentation at EASL in August. We initiated recruitment in Oregon two in July. August two is a Phase 2B randomized, double blind, placebo controlled 72 week study in approximately three hundred and forty subjects with biopsy proven NASH with fibrosis.

The primary endpoint of AREGO improvement of fibrosis, but without worsening of Nash and or Nash resolution without worsening the fibrosis. We're using EDP-305 doses of 1.5 milligrams and 2.0 milligrams, which we believe will favorably balance strong, efficacious target engagement with tolerability.

We're additionally developing EDP-297 follow on FSR candidates to NASH with potentially best in class, potency and targeted effects. That is when we presented two posters which demonstrated the treatment with EDP-297, demonstrated significantly reduced fibrosis progression and improved the liver function in a rat model at NASH.

We are encouraged by EDV-297 two nine seven clinical profile, which shows why target tissue distribution in the liver and intestine versus plasma and skin.

In September, we announced the initiation of a phase 1 randomized double blind, placebo controlled first in human study designed to assess the safety, tolerability and pharmacokinetics, including the effect of food intake of orally administered EDP 297 in approximately 74 healthy adult subjects.

The study includes two phases of single ascending dose space and their own six cohorts, including a two-part food effect cohort, and a multiple ascending dose stage, enrolling three cohorts.

We look forward to reporting clinical data in the second quarter of 20 By mid-year 2021, we expect to have important new insights for both EDP-305and EPS 297, which will inform next steps across our NASH program, we will know whether the tissue targeting and potency design elements we introduced in 2007 will allow us to better leverage FSR agonists compound without encountering tolerability challenges.

And at approximately the same time, we expect that ARGONE-2o will provide us an interim analysis at 12 weeks of treatment on a subset of patients to enhance our ability to prioritize our effects, our agonist compounds and seek opportunities more quickly for development of one or both of them in combination with other mechanisms for that.

We are encouraged by the efficacy demonstrated by FSR agonist for Nash with fibrosis, a disease with high unmet need, and believe that this mechanism has promised the potential therapeutic. We've accomplished all of this while we still managing the impact of COVID-19 on our lives and business.

I'm continually impressed by the team we have built and their ability to maneuver around the challenges with which we have been presented. I want to thank our very talented and committed employees who have worked tirelessly during the pandemic. Their dedication, is evidenced by the progress we've been able to make this year.

I'd like to conclude my remarks by emphasizing a few key points.

We made significant progress during our fiscal year, despite the multitude of challenges presented by the COVID pandemic, including the initiation of four new clinical trials, two for our EDV, four for our HBV program and two for our Nash program concurrent with conducting our ongoing Phase two, the program for RSV.

So here we are on schedule to initiate RSBPX, an adult transplant patient later this quarter, RSBV, in pediatric patients in the first quarter of 20 21.

We were also successful in moving our HBV trial in viremic patients forward, as well as in progressing our phase 1b, trial and HBV patients who are suppressed with preliminary data, expected studies in the second quarter of 2021.

And finally, we look forward to advancing our candidates in NASH with the ARGON-2 trial EDP-305 on the Phase 1 study of EDP-297. Looking toward 2021, we are poised for an exciting year with multiple data readouts anticipated across our pipeline. I'll stop here, and turn the call over to Paul to discuss the financials for the quarter.

Paul?.

Thank you, Jay. I'd like to remind everyone that Enanta reports on a September 30th fiscal year schedule. Today, we are reporting results for our fourth quarter in fiscal year ended September 30th, 2020. For the quarter, total revenue was 23.6 million and consisted entirely of royalty revenue earned on these global HCV products, sales of 414 million.

This compares to total revenue of 51.3 million for the same period in 2019. The decrease in our royalty revenue was due to lower global HCV product sales, as reported by AbbVie as treated, patient volumes have remained below precleared levels.

AbbVie now expects total HCV sales of approximately 1.9 billion for the calendar 2020 as treatments remain below pre-COVID levels.

A royalty revenue was calculated on 50 percent of average sales at a blend of our first and second royalty tiers of 10 and 12 percent, respectively, and on approximately 30 percent of accuracy of that royalty rate of 10 percent after adjustments for certain contractual discounts, rebates and set offs, which are now just over two percent of at least total reported HCB sales.

Royalties are calculated on a calendar year basis. Therefore, royalties in our fiscal first quarter ending December 31 will be calculated at the highest royalty rates of the year, and royalties for our fiscal quarter ending March 31st will be calculated at 10 percent, our lowest royalty rate here in our fiscal year.

You can review our royalty tier schedule in our 2019 Form 10-K. Moving on to our expenses, for the three months ended, September 30th, 2020, research and development expenses totaled 36.7 million, compared to 38.7 million for the same period in 2019.

This decrease was primarily due to the timing of our clinical studies year-over-year and COVID-19 related delays in two clinical studies that are now ongoing. General and administrative expense for the quarter was 6.7 million, compared to 6.2 million for the same period in 2019.

Enanta reported income tax expense of 10.7 million for the three months ended September 30th 2020 compared to an income tax benefit of 0.5 million for the same period in 2019.

The income tax expense in 2020 was driven by a non-cash valuation allowance recorded against our deferred tax assets of approximately 18 million, which was partially offset by seven point three million of NOL carry backs in R&D tax credits.

For the 12 months ended December 30th, 2020, Enanta’s effective, tax benefit was approximately 3% compared to an effective tax rate of approximately 2%for the 12 months ended September 30th, 2019. I'd like to note that the drivers of the decrease in the effective tax rate are covered in the press release.

Net loss for the three months ended September 30, 2020 was 29.3 million or a loss of 1.46 per diluted common share compared to net income of 9.2 million nine point two million or 44 cents per diluted common cheer for the corresponding period in 2019.

The net loss for 2020 was due to the decrease in HCV royalties earned under our AbbVie agreement, which were adversely affected by the COVID-19 pandemic.

And at the end of the quarter, with approximately four hundred and ninety million in cash and marketable securities, an increase of approximately 419 million from our 2019 fiscal year end balance of 400 million.

Notwithstanding our current level of operating losses, our existing cash balances, together with our ongoing royalties are expected to be sufficient to fund their operations for the foreseeable future.

Regarding guidance for fiscal 2021, we expect our research and development expense to be between 145 million and 165 million and our general and administrative expense to be between 27 million and 33 million. Further financial details are available in our press release and will be available in our annual report on Form 10K when filed.

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

[Operator Instructions] Your first question comes from the line of Roy Buchanan from JMP Securities. Please go ahead..

Hi, Greg. Thanks for taking the questions. I had a few on RSVP program.

So, for RSVP, it sounds like there are more set versus the last quarter in terms of adding Asian sites in 2021? Does the Northern Asian season margin mimic in North America and can you provide any specifics on the potential Asian site with China included?.

Hi, this is Jay. In terms of Asia and different countries, it’s slightly different seasons. Some are actually almost year around. So, in the broader perspective, you know, when we work it with Northern Hemisphere, U.S.

and Canada, and we look at Europe and we think if we can build on Asia, that will be getting coverage somewhere for, you know, maybe nine or seven months a year.

And so, I think, you know, specifically, we'll come back later with, you know, other Asian countries and in particular that we're that we're picking up, that that's the plan is to continue to add in the wake of the 2021 timeframe. Of course, in the meantime, we'll have lots of North American states on board.

You recall we were pointing out, you know, dozens of them previously. So, you know, we'll have approaching 50 North American sides and hopefully at least that many more than the end of the year. So really kind of all this stuff that for many, many states..

So, are any of the North American sites yet open? Do you have any feedback from those sites?.

It's just coming up, you know, but what we can tell is, you know, if you recall last year, the season came early and so this year versus last year, it's a little quiet so far this year. And, we'll just have to keep an eye on that side of the screen. But in general, the rates and you know, those stats by sincere are, you know, pretty quiet right now.

We'll just have to wait and see as the season progresses.

And with the backdrop of COVID and social distancing and the like, you know What's the difference?.

Ok, great. I had a couple on the on the new phase two trials, if you don't mind, so far as the iPad, how many patients are you planning on? The endpoint is progression to lower respiratory tract infection.

And in from that trial we have investigators lined up, I guess any kind of similar to the last question, just how are they doing the current situation and the feasibility of starting the trial?.

I'm sorry, are you talking about the PED study? You know, so the you know, the PEDs front, you know, we're aiming to start in the next quarter. We're aiming for about 90 patients’ total. And so, I think those are the you know, the main points in terms of the study itself, you know, part one's going to be safety and peak.

And then the other part, too, will be looking at the actual virus. So, change, change and RSV shutting with one of the things that we look out. for here to be given name 380 or placebo for five days. And, you know, we'll be looking at cohorts up to 24 months of age..

Okay. Great. Then one last one on the transplant So how many safety planning for that one? Are you also including Europe and as any information on the current RC r transplant setting, either in the U.S. or elsewhere? Thanks..

I don't think so. The sites, you know, will come on line will be at numerous sites, will be a global studies that will have sites on and all the obvious sort of territories where you will be looking at 938 versus placebo for 21 days and, you know, doing it a little bit longer because the patients are, you know, obviously immune compromised.

There aren't a lot of statistics on this specific patient population. So, this could set up a lot of the e centers during the you know, the normal season and, you know..

Your next question comes from the line of Bryan Scotney from Barrett. Please go ahead..

Hi, thank you. This is Jack dialing in for Bryan. Thanks for taking our questions. We just have one quick one. We're wondering about if you had any updated thoughts with regard to the opportunity for inhibitors in light of the disappointing news from the assembly and their core plus new regimen and the sustained virla response data we saw there.

I know you're looking at the triple combination internally as well, but we were just wondering what your thoughts were? Thank you..

Yes, so it’s an interesting data set. You might have to hand it to them for doing the study, the study of which, you know, was looking at a core inhibitor plus a new class time. So, the question is, could a core pose a new class time getting to a functional cure? And again, nobody knew the answer to that question.

They looked at different time points over the course of the investigations, three months and six months, a year and so forth. And, you know, what I - the results that were produced in this in this initial study weren't particularly positive. You know, there could be a lot of different reasons there.

It’s either new capacity or plus more time? You know, although they went for, you know, 12 to 18 months. So, it is a -- it's a good chunk of time. It's possible that the first generation, co-inhibitor wasn't, you know, take a nap. I think that's among the reasons why they're working on.

ADP-514 arms are core inhibitor, is roughly ten times more potent than the one that you're referring to in that study.

And then another possibility, of course, is the core of the new, plus a third agent that actually, you know, be the one in strategy to get you there., Just applying enough pressure on the virus and from different angles and from different stages of mechanistic intervention.

And so, you know, all along we've been working on multiple different mechanisms. So we’d have something in addition to a new core inhibitor, and we're making pretty good progress on that front.

So, I think earlier next year, we'll have more to sort of discussion around our progress on that front and then also on our strategy of coming up with a potential triple. I think for us, we're highly focused on all oral treatments. As you know, some of the - well, historically people have used interferon as an injectable.

You know, we've got a new but it's sort of a poorly tolerated treatment that leads to very, very low cure rate. Other folks have been using some RNA approaches to add injectables to oral agents. And that's an interesting approach that some others are taking. We're highly focused and committed to.

If we can come up with an all oral approach, we think in the end, having oral therapies, you know, potentially could be put together as a fixed dose combination and that could be disseminated to the millions of people, hundreds of millions of people globally that suffer from this infection that that would offer significant advantages overall.

So highly focused on all oral agents and hopefully with the addition of a new [indiscernible]..

And your next question comes from the line of Akash Tewari from Wolfe Research. Please go ahead..

Hi. This is Emily on for Akash. Thanks, thanks so much for taking your questions. We just heard several on RSV and then one on HPV.

So, if you're starting with your Phase 2b cell transplant, do you have any data supporting the safety of longer-term dosing with EDT-938? And then why did you set the symptom onset cut off to be three days instead of two days like you did for outpatient adults? And then on the RSV outpatient trial, how many patients are currently enrolled in this trial? And is there any way to modify it into a Phase 2/3 registrational trial? Additionally, how are you ensuring that patients will be dosed within the right time window? And then one last one on HBV.

One hypothesis, why SMV core inhibitor failed is that the drug doesn't completely stop the formation of new CPC DNA. And we were just wondering what the in vitro or in vitro potency of EDP-514 is to specifically inhibit EDP DNA formulations? Thank you..

Well, let's start with the first one. So, three days versus two days in terms of transplant, I think it's no accident. It's in the range we're looking at. You know, 48 hours was the inclusion criteria for RSVP. There was nothing special about that other than we believe that, you know, [indiscernible] are always likely to be better.

You know, flu drugs are often within two days or three days and so 48, 72 hours. And there are probably pretty reasonable timeframes to be looking at. We certainly have all the talks. He asked, you know, to support this type of study progressing forward. So, what were some of the other questions? Couldn't write them down.

Hello, did you go off the line?.

Hello, can you hear me? I apologize for that.

Yeah, so for the RSV outpatient trial, how many patients are currently enrolled and is there a potential to modify it into some sort of a phase two three registrational trial?.

Well, I think this is really a case to study, you know, that we're using to capture the initial data in that patient population. So, our plan is for it to be a phase 2. We don't really discuss, you know, the recruitment on ongoing trials other than to set targets for where we are and know where we expect to have data.

So, it's going to be clear, R.S.V.P. is not a registrational study, but instead to be supportive of the entire program overall and to better assess the feasibility of the window, et cetera. And so, we again are able to get people to arrive with symptoms within the 48-hour timeline.

And so, again, I think the you know, the bigger wild card is, what will this season be in the presence of social distancing and potential lockdown? So that’s something that, you know, no one has any idea. We'll just have to go into and sort out..

Okay. Great, thank you.

And then a last question on hepatitis B, just wanted to know what the in vitro and in vivo potency of EDP-514 is specifically on inhibiting DNA formation?.

In terms of CPP DNA information, as I recall in the -- it's in the [indiscernible] honestly it was around 30 nanomolar or so. Again, this is something that you determine in vitro at the time of conception. So, 30, 30 nanomoles sticks in my mind. .

Your next question comes from the line of Yasmeen Rahim from Piper Sandler. Please go ahead..

Hi, team, I have two questions. Maybe the first question is, what do we know about the viral kinetics, obviously, of RSV is different between, you know, hospitalized Pete Schwartz, a pediatric patient, versus immunocompromised. And how do we really captures its efficacy in the next stage of development? I think commenting on that would be helpful.

And then the second one question is, recently at the meeting, we saw data from another agonist that had very encouraging biomarker data but failed to achieve histological benefits.

So how do we think about sort of the myth of correlation, especially as we think about, you know, data for the first generation and second-generation agonist?.

I'm sure so starting with the second question first, I think triple facts are, is the first time you're going to correct it within a 48-year study. And they did see a lot of the markets moving in the right direction. But they didn't see it.

I don't think they had fibrosis improvement, and I think one of the key differences is, you know, people generally intercepts the results as being the sort of the benchmark ones to be looking out for the leadership and the class. And I think one of the big differences was they didn't go seventy-two weeks.

So that's obviously will be built into our ARGON-2 study. And again, many people, you know, have looked at shorter duration ones on various levels of success in terms of trying to demonstrate an effect on fibrosis. So we just got to study this thing through work and designed ARGON-2, accordingly. So I think the other thing is the Novartis study.

You know what? I don't believe it was used the power in terms of numbers of subjects also. So I would question, I guess, you know, the power in order to get a defense from a placebo and also the shorter duration of the study that they did, I think is going to be so to one point to just necessarily going to be once one is to be more patient than. On.

And you have to usually present with the upper airway infection, they have a high viral load in the upper respiratory tract initially.

And you know, the key, whether it's immune compromised or not, is to, you know, make sure try to prevent, try to catch the infection and it's an upper airway infection and prevent it from the virus from sort of going down the elevator shaft into the lower airway, which is where, you know, you start to have as much of an inflammatory disease going on as you do in the viral disease.

I think symptoms can be explained of specific outcomes, scale and transplant. You know, you will be looking for patients that have an upper airway disease and try to, you know, have the prevention of the lower airway complications.

It's I’m not specifically able to point to this right now, anyway, I'm not so keen to add on the, you know, the differences in terms of how that fire, of course, plays out of compromise one. But I do believe you no longer treatment duration is warranted in that patient population..

Thank you so much for answering my questions..

Your next question comes from the line of question comes from the line [indiscernible]. Please go ahead..

Hi, thanks for taking my question. I have two quick ones for you. I think the first one is I that you've been really busy with multiple studies. So I'm just curious about the point RSV study.

Do you think that they could hamper the enrollment of the ongoing Phase 2b study? Also, what are some of the risks that you think could positively the studies that mention increased costs associated with some studies they installed on delayed?.

So what was the first part of the question? We're not competing for one another, the studies..

Yeah, just competing for enrollment, or do you not expect that to be a problem?.

Among our studies or between our studies and other studies?.

Between your studies..

Yeah, now I think they're. You know, they each requires significant internal resource, but, you know, they they're very different and diverse patient population, so I don't expect any real challenges there. The question on COVID there is. There was a question.

I mean, we do know, you know, people have been studying up for the southern hemisphere, you know, and no spring. No one really knew what the winter time would look like in the southern hemisphere.

And that transfer due to a lot of good mitigation strategies that places like New Zealand were right on top of, you know, they were able to stem the tide of COVID significantly. But with that, due to travel bans and lockdowns, social distancing and closing things up, they did pretty much prevent many other respiratory viruses from early occurring.

And to that end, you know, you can look at it through as one of the major samples for that in RSV as well. So there is very little with regards to that that some of the other respiratory infections due to covered mitigation strategies.

And now we're narrowing down to what looks like a pretty nasty TB situation emerging in the northern hemisphere, particularly in the U.S. and EU. And so, we'll just have to -- just have to see, you know, the most we can do is have sites set up everywhere and will have approximately 100 sites in the U.S., EU and ultimately in parts of Asia.

And, you know, to try to capture a total of 70 patients. And but it is going to be in some major covid dependent, I think, you know, hopefully we won't have some of the specific trial impact that we had in the earlier quoted ways in North America. But no one can rule those sorts of things.

And we'll just have to see what some of the social distancing and other sorts of things plays out in terms of rate of diagnosed RSV and other consequence. So, two, we're rolling into, but we'll just have to watch. .

Makes sense.

Just a quick follow up here about the Nasdaq expected in mid-2021? How much data you would be acceptable would you actually like to have at the time beat out and then based on the enrollment that you're seeing now, are private and argue that you'll be able to keep that?.

Are you talking about 305 for ARGON-2?.

Yeah, I suppose both for the [indiscernible]?.

Yes. Okay. While we're on track. I mean, the guidance that we gave, we have to get some and back to you. We have a lot of catalogs coming in sort of the first half of the year and have to and HPV.

And in the second quarter, we're also expecting to have data from our follow on FSR 297 in the second quarter in and in our Phase 2b studyEDP-305, the so-called ARGON-2 study.

You know, we're hoping to have enough patients hit the target for the interim analysis threshold that we can, you know, then have that inform decision making around the whole NASH program. So again we’ll have -- then we have all kinds of data, you know, to look at in that time frame. Right now, things are running along and going generally smoothly.

So anything can happen in the middle of next year with regards to COVID. But it would be something that we're not currently seeing, that we're on track for those, you know, targets that we guided to today..

Looking forward to the most updates. .

Well, thank you..

Your next question comes from the line of Eric Joseph from JP Morgan. Please go ahead..

Good evening. Thanks for taking the questions. from our recent interactions with KOLs. Well, there's a lot of interest in pursuing ethics charges, a combination regimen, and you talked about exploring some FXR modalities in NASH.

What's your latest thinking on the role of extractives mechanism to partner with either three or five in 2007? And do you have a sense of whether development of a combo and travel agencies would be feasible as an initial registration strategy. Thanks..

No, thanks. And so, you know, I think if I start combo's are really interesting, you know, because there are some elements of FXR.

I mean, FXR is a little bit of a sort of a utility tax are I mean, if I start as a little bit of a sort of a utility that are I mean it because after some of the pro fibrotic mechanisms, it's got some anti-inflammatory components and it's also, you know, effects metabolically. And so these are some of the hallmarks of the disease..

So as such, it could really talk to, you know, many of the different mechanisms that are, under study and, you know, there are a bunch of them out there. So I think, there was a reasonably solid rationale to tuck-in FXR and with virtually any of the other courses..

You know, ultimately in terms of combination strategies, I think, you know, clearly some people are thinking of fixed dose combinations. And there are some people who are thinking of maybe taking a single agency forward so that they can be mixed and matched. I think I think both of those are possibilities.

But in the end, you know, you're going to need likely to have had a combination plan.

And now our plan is to generate, you know, interesting in the case of three or five interesting Phase 2 datasets that will enable us to, you know, even having checked at the interim analysis at 12 weeks next year to then think about peeling off a dose that could then be used in combination with another agent from somewhere else.

So that's the plan there, I think, as the field matures. This is very likely to end up within combinations that if they're all, you know, could be potentially those combinations.

I know that was you know, one of the approaches that delivered was clearly taken at the beginning when they were looking at their multiple single mechanisms and in combinations, it's almost reminiscent of the days of Hep C. And so that's following it down further on. But the combination studies show promise of one sort or another.

I would imagine that people will go forward with combinations for approval..

Okay, great. And just a follow up on HPV, if I could. Well, just pick up on your comments about the potential for an oral regimen, any way you can share on what the third leg of the might look like. And I guess, is there a protease component to the HCV lifecycle that could be a life cycle that could be adopted here.

And I guess there will be a when you're able to say more about what the mechanism might be, would you be surprised on its identity relative to some of the other? Points in the left cycle that are being pursued so far appears to be HCB..

Well, thanks for the question. We're not quite ready tonight to, you know, to sort of unfurl that, but we expect that we will be by early next year. So, you know, on that front. Stay tuned. But, you know, we've been sort of grinding the way for a long time in the background on other stuff. I mean, we've sort of hinted at that over time.

And I think we're getting to the point now where some of this is hopefully getting pretty close. So and then our plan is to try to go for oil. But speaking out tonight..

Your next question comes from the line of [indiscernible] from RBC Capital Markets. Please go ahead. .

Starting on NASH. I was wanting to speak broadly about your views on the evolving regulatory landscape there and how you might incorporate that into the development program.

For instance, are there additional noninvasive tests you may explore to ensure easily translatable methods for identification of patients or a benefit risk of FSX? Do you have any views on what the accelerated approval endpoints are and whether those might evolve? Thanks..

Yeah, well, thanks for the question. In our world, everybody is focused on trying to get rid of biopsies because not only, you know, one point, that is one that is important for approval, but also in terms of more robustly, not looking for a noninvasive test could stratify patients.

You know, in a better way and also, you know, perhaps give you a more informed and reliable read out histologic endpoint. So, we'll be working on with the scientific community to explore this within our programs.

We hope that the landscape will change before our registration study and there is a chance for the drug or at least a chance that it may not. But nonetheless, the field is moving very solidly in that direction.

There's a lot of, you know, encouraging signs, you know, even coming out of the Saudi, you know, on that front, it's probably not quite right there.

But for now, we're still including the strategic results, obviously, it's funny because that is the, you know, the past at this time, at least in terms of, you know, targeting, you know, proving one point. But I suspect that landscape will change and it could change by the time. You know, one is ready to face that..

Got it. And then on the earlier stage, respiratory problems, human metapneumovirus and SARS-CoV-2. Just wondering if you could talk about the potential timelines for development there, once you select lead candidates.

And what's the -- how of the recent success of vaccines for COVID-19 impact your prioritization of development among those early stage programs? Is there a role you would still potentially see for a COVID-19 therapy, for instance, and stockpiling? Thanks..

Yes, so, absolutely. I think, you know, we're like three weeks in and including, I guess in part today, there's been a lot of news on the vaccine front and much of it, you know, quite encouraging. It's the sort of things we know and the things we don't know.

One other one we don’t know what the efficacy rates are going to be, you know, broadly across all sorts of different patient population. That’s number one. Nor do we know that although there are some encouraging signs that everybody may be in a good direction.

But, you know, you just really need a lot more information to, you know, understand how fully efficacious vaccines are and further, you know, how much they do or don't have the need for therapy. I think, you know, there's questions about even long-term safety. There’s questions about compliance in terms of getting vaccinated.

And so, you know, for the foreseeable future, I think there are going to be people for one reason or another who turn up testing positive for cocaine. And to that end, particularly in people who are asymptomatic or otherwise fairly early in a stage of their infection. This is where it makes fantastic sense, you know, to have a therapeutic.

So, we'll continue down this path with the full expectation that there will be the need in some form for therapeutics. With regards to that and human metapneumo, which is a virus for which there is no current vaccine same with RSV. I’m not coming back to human metapneumo. And our SARS-CoV-2 program.

I'd say they're tracking, you know, pretty similarly right now, even though we I mean, we announced our human metapneumo program in January with some early leads, and then we announced, you know, the start of this beginning to work at SARS-CoV-2 in the March timeframe. But the scientists have made really good progress.

I’d say we’ve got potent molecules, very potent molecules from against both of these viruses. And we're now turning, you know, potent molecules selection of potent molecules into, you know, the finalist candidates for clinical development. So, we're targeting to have, you know, hopefully one from each of those programs as a candidate for next year.

And then, you know, some of the time I think you want to part of your question was from the time of your candidate selection, how long until you get it in the clinic? You know, there you've just got to finish a lot of IND-enabling things. But, you know, typically, you know, nine, 10 months, something like that is often achievable.

And so the criteria that we use to, you know, nominate our candidates. So, again, we're hopeful to try to harvest the candidates for each of these viruses next year, which would really began to round out, you know, as our goal is really building out sort of the leading human respiratory virus portfolio, you know, with the flagship RSV, you know.

In just, you know, weeks, we expect we'll have, you know, three different Phase 2s going on, just why we haven't started working on RSV research, we're still exploring other mechanisms there to consider them, not because we have tremendous faith in [indiscernible], but we just want to continue to establish a leadership position there.

I’m looking at, you know, any reasonable mechanism, start comparing them, even looking. We don't think we need combinations so seriously that maybe there is a certain patient population that will profit from having a combination. And if that's the case, we would love to have that for and off the shelf stuff that we have and have 100 percent ownership.

So that's going on in RSV again. Again, hopefully soon we'll be supplementing that with a human metapneumo, our agent human metapneumo second lien cause pretty much everything RSV causes. And then, you know, COVID therapeutics, too. We've got, you know, a watchful eye on how vaccines are going to play there.

But again, I think there was no one who wouldn't want to have an effective COVID-19, SARS-CoV-2 agent available to them, something that was safe and oral and that could be administered early stages, you know, from the first sign of a positive test, and without needing to head into an infusion center, either for a monoclonal antibody or an agent, that's injectable.

So, you know, this remains a strong goal. And I think in the aggregate, it really builds out an interesting sort of portfolio of human respiratory [indiscernible]. .

Great, thanks so much..

You're welcome..

Your last question comes from the line of Jay Olson from Oppenheimer. Please go ahead..

Hey, guys, thanks for taking our questions. We have two of them. The first question is about GSKs RSV vaccine, which they announced today was moving into a Phase 3 study.

If that vaccine is eventually successful, would it have any long-term impact on your view of the market opportunity for a RSV therapeutic? And then we have another question about NASH..

Yeah, you know, maternal vaccine. Is that right..

Yes, that's correct..

Yes, I mean, that approach has been tried before and had promising results in Phase 2 and we have to hold up in Phase 3 studies.

I think there is, you know, just a fair number of questions around, that strategy, not aleast of which is, you know, the degree of penetration and compliance in terms of doing, you know, mandatory or not mandatory, but doing broad vaccinations of lots of pregnant women for something that, you know, may or may not end up being, you know, a big issue.

And so, I think there's other questions that are, you know, reimbursement questions.

You know, how are these things getting paid? You know, will people really reimburse for something that’s again, it’s just a question as to the dollar value for Jennifer Garner there, because, some of these vaccines may not be that durable and you're ultimately just maybe postponing the inevitable.

I mean, children reliably get RSV infections, and if they do, they usually rely on a few years of susceptive RSV infections to sort of build up a certain immunity to it. But if there is a break in that, so that is not a durable one, you're going to be prone to getting these infections.

So I think it's big questions around the efficacy piece of so, that approach. And once again, one in which I think you would want to still have under an even under any vaccine scenario, a robust armamentarium well, it’s a small molecule of therapeutics So there's I think there's been safety hurdles in that area..

Okay. Great. Thank you.

And then second question is about NASH, and we are wondering if the CRLs that intercept received and then the subsequent work they're doing to resubmit their NDA have any impact on your own development plans for FXR agonist in NASH? And specifically, if you would consider targeting a narrower NASH patient population with advanced fibrosis?.

I think we just need to fully understand the situation. I'm not sure anybody really knows, you know, all the details around that CRL. For us and for our immediate next steps they’re on a certain path that we've, you know, outlined and defined again today.

And they're not you know, there's so there's literally no impact of that based on either on our current ongoing activities. I think, you know, we as a NASH company in part and all other NASH companies, you know, should be watching. You know what that CRL amount just the way you understand watching.

You until we have a lot more granular detail around it and I'm hesitant to, you know, sort of recommend change as at this time.

Okay. Great. Thanks for taking the questions and have a happy Thanksgiving. .

You too..

Thank you..

I will now turn the call back over to Jennifer Viera for closing remarks..

Thank you, everyone, for joining us today. If you have any additional questions, please feel free to give us a call or send me an email. Thanks so much. Have a good night. Bye bye..

Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect..