Q3 2020 Enanta Pharmaceuticals Inc Earnings Call

Good afternoon, and welcome to an Endo Pharmaceuticals fiscal third quarter conference call. At this time, all participants are to listen only mode. It will be it why she didn't and she's section at the end of the prepared remarks.

Operator: Good afternoon, and welcome to Enanta Pharmaceuticals' fiscal third quarter conference call. At this time, all participants are in listen-only mode.

Operator: 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 will now turn the call over to Jennifer Viera, Senior Director, Investor Relations.

Please be advised that this call is being recorded I will now turn the call over to Jennifer Viera Senior Director Investor Relations. Please go ahead.

Jennifer Viera: Thank you, operator. And thanks to everyone for joining us this afternoon. The news release with our financial results for the recent quarter was issued this afternoon and is available on our website. On the call today are 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, I want to remind you that we will be making forward-looking statements, which may include our plans and expectations with respect to our product candidates 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. 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?

Thank you operator, and thanks to everyone for joining US. This afternoon news release with our financial results for the recent quarter was issued this afternoon.

Visible on our website.

The call today is Dr., James <unk>, President and Chief Executive Officer.

Paul Mellett, our Chief Financial Officer, and other members of Enantas Senior management team.

We began with our formal remarks I want to remind you that we will be making forward looking statements, which may include our plans and expectations with respect to our product candidate and financial projections, all of which involves certain assumptions and risks beyond our control it could cause our actual developments.

And results could differ materially from those statements a description of these risks in our most recent form 10-Q and other periodic reports filed with the FCC Anantha does not undertake any obligation to update any forward looking statements made during this call.

Now I'd like to trying to call over to Dr., Jay life, President and CEO Jay.

Thank you Jennifer.

Jay R. Luly: Thank you, Jennifer. Good afternoon, everyone. Thank you for joining us today. I'm pleased to report the progress we've made during the quarter across our pipeline, which is focused on our two areas of expertise, virology and liver disease, with programs in respiratory syncytial virus, hepatitis B virus, human metapneumovirus, SARS-CoV-2, and non-alcoholic steatohepatitis. On this call, I will discuss clinical and preclinical updates across our pipeline, and Paul will review the financials for the quarter. Before I get into my formal remarks, I want to take a moment to welcome Mark Folletta. This appointment was announced in June to our board of directors. We're very pleased to have Mark join our team, where he will serve as Chair of the Audit Committee and will be a member of the Nominating and Governance Committee.

Good afternoon, everyone. Thank you for joining us to theirs.

I'm pleased to report the progress we've made during the quarter across our pipeline.

The speakers for one or two areas of expertise by Raleigh Street and never disease.

Grants and respiratory syncytial virus hepatitis B virus.

You're talking about a neutral virus Sars coke too.

Non alcoholic steatohepatitis.

On this call it will discuss clinical and preclinical updates across our pipeline and Paul reviews, the financials for the quarter.

Well get into my formal remarks, I want to take a moment to welcome Mark Florida.

We think there that we announced in June to our board of directors.

We're pleased to have Mark joined our team where he will serve as chair of the audit Committee will be a member of the nominating and governance Committee.

Jay R. Luly: Mark has extensive financial, operating, and governance experience, previously serving as chief financial officer for various biopharma companies, including Amelin Pharmaceuticals. Mark will be instrumental in helping us as we advance our pipeline of innovative treatments for viral infections and liver disease. Additionally, I want to take a few moments to comment on the resilience of our team here at NASA.

Mark has extensive financial operating and governance experience previously served as chief financial officer, various biopharma companies, including an animal in pharmaceuticals.

Well it will be instrumental in helping us as we advance our pipeline of innovative treatments for viral infections and liver diseases.

Additionally, we want to take a few moments to comment on the resiliency of our team carried an answer.

Jay R. Luly: Despite the backdrop of the ongoing COVID-19 pandemic, the team has been able to stay focused, ensure that our business progresses, and that our pipeline continues to mature. We have clinical studies ongoing with three different compounds. We are preparing a fourth compound to move into the clinic this quarter, and we are continuing our work to develop candidates for human metapneumovirus and SARS-CoV-2. To that end, I'll begin with our virology-focused programs, where we are leveraging our antiviral drug discovery expertise to discover and develop multiple product candidates. I'll start with EDP514, our lead core inhibitor in our HPV program that is currently being tested in both Viremic HPV patients and Nuke-suppressed HPV patients. We are committed to developing a treatment for HPV, as it is a disease with a true unmet need. It is estimated that HPV affects more than 250 million people worldwide.

In our work to develop candidates for human met a name of Rs and Sars Cove too.

To that end I'll begin with our virology focused programs, where we are leveraging our antiviral drug discovery expertise to discover and develop multiple product candidates.

I'll start with GDP five one for our lead core inhibitor and our HBV program that is currently being tested in both library make HBV patients and nuke suppressed HBV patients.

We are committed to developing a treatment for HPV as it is a disease with a true unmet need it's estimated that HBV effects more than 250.

Million people worldwide.

In early July we announced that we initiated our phase one clinical trial and by remake HBV patients. This randomized double blind placebo controlled phase one be study and by remit chronic HBV subjects not currently on therapy is designed to evaluate the safety tolerability.

Jay R. Luly: In early July, we announced that we initiated our Phase 1b clinical trial in viremic HPV patients. This randomized, double-blind, placebo-controlled, Phase 1b study in viremic chronic HPV subjects not currently on therapy is designed to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of orally administered EDP514 over a 28-day period. The study is planned to enroll 24 subjects who will be randomized to receive one of three multiple ascending doses of EDP514 or placebo at our clinical trial sites in Hong Kong and Taiwan, which are both areas with a large unmet need for HPV treatment. As we continue to monitor the impact of COVID-19 in these regions, we expect preliminary data from this trial in the first half of 2021. We've also resumed our ongoing, randomized, double-blind, placebo-controlled Phase 1B study in chronic HPV patients treated with nucleoside reverse transcriptase inhibitors, which we refer to as nuke-suppressed patients. This study, which was paused in March due to the COVID-19 pandemic, is part two of our phase 1A, 1B study. Part 2 is designed to evaluate the safety, colorability, pharmacokinetics, and antiviral activity of orally administered multiple ascending doses of DP514 over a 28-day period.

Metrics and antiviral activity of orally administered GDP five one for over a 28 day period.

The study is planned to enroll 24 subjects, who will be randomized to receive onex three multiple ascending doses of GDP five one for or placebo.

And our clinical trial sites in Hong Kong, and Taiwan, which are both areas within large unmet need for HPV treatment.

As we continue to monitor the impact of Cobot 19 in these regions. We expect preliminary data from this trial and the first half of 2021.

We've also resumed our ongoing randomized double blind placebo controlled phase one study and chronic HBV patients treated with nuclear side reverse transcriptase inhibitors, which we referred to as nuke suppressed patients.

This study, which was paused in March due to the twin due to the cobot 19 pandemic is part two of our phase one a one be study.

Part two is designed to evaluate the safety Tolerability pharmacokinetics and antiviral activity of orally administered multiple ascending doses of PDP five one for over a 28 day period.

The study is planned to enroll 24 subjects, who will be randomized to receive one of three multiple ascending doses of GDP by one for where placebo.

Jay R. Luly: The study is planned to enroll 24 subjects who will be randomized to receive one of three multiple ascending doses of DDP-514 or placebo. Similarly, or in any further COVID-19 disruptions, we plan to have preliminary data in the second quarter of 2021. As a reminder, we plan to present the first human data from part one of the phase one study in healthy volunteers in a poster presentation at EASL's Digital International Liver Congress being held August 27th through the 29th. Now, let's turn now to EDP938 and our program for respiratory syncytial virus, or RSV. RSV is a severe respiratory infection associated with significant morbidity and mortality in infants, the elderly, and immune-compromised adults, a condition for which there is currently no safe and effective therapy.

Barring any further cobot 19 disruptions, we plan to have preliminary data in the second quarter of 2021.

As a reminder, we plan to present first in human data from part one of the phase one study in healthy volunteers in a poster presentation at Easels digital International liver Congress being held the August 27 through the 29.

Let's turn now to 89 create on our program for respiratory syncytial virus or RSV.

RSV is a severe respiratory infection associated with significant morbidity and mortality and thats, the elderly and immune compromised adults at a condition for which there is currently no safe and effective therapy.

GDP nine create as a potent non fusion inhibitor of RSV, a and Rsvb has been shown in significant reduction in viral load and symptom resolution and topline data from a phase two human challenge study.

Jay R. Luly: EDP-938 is a potent non-fusion inhibitor of RSV-A and RSV-B and has been shown to significantly reduce viral load and symptom resolution in top-line data from a Phase II human challenge study. We are currently initiating sites in the southern hemisphere for RSVP, our ongoing Phase 2b study of EDP938, and are also keeping our existing North American sites ready for reactivation with the arrival of the fall and winter RSVP season, as well as adding a number of new sites in Europe. RSVP is a Phase IIb, double-blind, placebo-controlled study of EDP938 designed to enroll approximately 70 subjects up to the age of 75 years who were randomized to receive either 800 mg of EDP938 or placebo for 5 days. The primary objective of the study is to evaluate the effect of EDP938 on the progression of RSV infection by assessment of clinical symptoms measured over the course of the 14-day study observation period, and any viral efficacy will be evaluated as a key secondary objective.

We are currently initiating sites in the southern hemisphere for RSVP, our ongoing phase Twob study of ATP nine create and are also keeping our existing north American sites ready for reactivation, what the arrival of the fall and winter RSV season, as well as adding a number of new site.

In Europe.

RSV is RSVP is that phase twob double blind placebo controlled study of Edp nine create designed to enroll approximately 70 subjects up to the age of 75 years randomized to receive either 800 milligrams of GDP nine create or placebo for five days the.

Primary objective of the studies to evaluate the effect of 89 threeeight on the progression of RSV infection by assessment of clinical symptoms measured over the course of the 14 days study observation period, and any viral efficacy will be evaluated as a key secondary endpoints.

Well, it's too early to know what impact Cobot 19 will have on RSVP timelines, assuming full study enrollment and the northern hemisphere. This upcoming what are we would expect to have data in the third quarter of 2021.

Jay R. Luly: Well, it's too early to know what impact COVID-19 will have on RSVP timelines, but assuming full study enrollment in the northern hemisphere this upcoming winter, we would expect to have data in the third quarter of 2021. Meanwhile, we are on track to initiate two additional Phase 2 studies with EDP938, one in pediatric patients and one in adult transplant patients by the end of this year, concurrent with the RSVP study. The pediatric trial will be a Phase II randomized, double-blind, placebo-controlled, dose-ranging study of EDP938 to evaluate EDP938 regimens in hospitalized or non-hospitalized infants and children aged 28 days to 24 months who test positive for RSV based on an approved diagnostic assay. The Adult Transplant Study is a Phase 2b, randomized, double-blind, placebo-controlled study of EDP938 Turning to the rest of our virology franchise, we remain focused on developing a candidate for SARS-CoV-2. We are utilizing our core strength in compound optimization and drug development to understand the virus and identify vulnerabilities to exploit intracellular targets using, for example, protease inhibitors and polymerase inhibitors. These are direct-acting antivirals, often referred to as DAAs.

Meanwhile, we are on track to initiate two additional phase two studies with PDP 9381 in pediatric patients and won an adult transplant patients by the end of this year concurrent with the RSVP study.

The pediatric trial will be a phase two randomized double blind placebo controlled dose ranging study of edp nine create to evaluate DDP nine threeeight regimens and hospitalized or non hospitalized infants and children, aged 28 days to 24 months.

Who test positive for RSV based on an approved diagnostic assay.

The adult transplant study the phase to the randomized double blind placebo controlled study of GDP nine create to evaluate the effective edp nine create and adult hematopoietic cell transplant recipients with acute RSV infection of the upper respiratory tract.

Turning to the rest of our biology franchise, we remain focused on developing a candidate for Sars Cove too.

We are utilizing our core strength and compound optimization in drug development to understand that virus and identify vulnerabilities to exploit intra cellular targets using for example, protease inhibitors and preliminaries inhibitors.

These are direct acting antiviral as often referred to as D.A.

As with RSV, we believe these D.A. should be more effective than entry inhibitors and stopping the virus after patients already shows symptoms of infection.

Jay R. Luly: As with RSV, we believe these DAAs should be more effective than entry inhibitors in stopping the virus after patients already show symptoms of infection. Chemistry and biology efforts are actively ongoing, and we hope to make important progress throughout the remainder of the year. Moving on to our second emerging program, earlier this year, we also introduced a drug discovery program for human metapneumovirus, also known as HNPV. Similar to RSV, HMPV is a pathogen that causes upper and lower respiratory tract infections in young children and the elderly, as well as in immunocompromised patients or those with COPD or asthma.

Chemistry, and biology efforts are actively ongoing and we hope to make important progress throughout the remainder of the year.

Moving on to our second emerging program.

Earlier. This year, we also introduced to drug discovery program for human better numerous also known as each NPV.

Similar to RSV HPV is a pathogen that causes upper and lower respiratory tract infections, and young children and the elderly as well as an immuno compromised patients are those with C O PD or asthma.

We continue to perform and optimization of our current nanomolar each NPV inhibitor leads and aggressively working to identify our first clinical candidate for this indication.

Jay R. Luly: We continue to perform optimization of our current nanomolar HMPB inhibitor leads and are aggressively working to identify our first clinical candidate for this indication. Shifting gears to our work in non-viral liver disease, where we currently focus on NASH, we are conducting clinical studies of EDP305, our first FXRI. Based on data from Argonne 1, which will be highlighted in an oral presentation at ESOL later this month, we initiated recruitment for Argonne 2 in July. ARDAN2 is a Phase IIb randomized, double-blind, placebo-controlled, 72-week study in approximately 340 subjects with biopsy-proven men. The primary endpoint of Argon 2 will be improvement of fibrosis without worsening of NASH or NASH resolution without worsening of fibrosis.

Shifting gears to our work in non viral liver disease.

Where we currently focused on Nash, we're conducting clinical studies of GDP Threeo five are Onest FXR agonist.

Based on data from Oregon, one, which will be highlighted and an oral presentation at easily later this month, we initiated recruitment and Oregon to in July.

Our again to as a phase twob randomized double blind placebo controlled 72 weeks study and approximately 340 subjects with biopsy proven Nash the.

The primary endpoint of Oregon to will be improvement of fibrosis without worsening of Nash and or Nash resolution without worsening of fibrosis.

We are using eating edp 305 doses of 1.5 milligrams and two milligrams, which we selected to provide strong target engagement on a balanced profile in terms of efficacy and tolerability.

Jay R. Luly: We are using EDP-305 doses of 1.5 mg and 2 mg, which we selected to provide strong target engagement and a balanced profile in terms of efficacy and tolerability. Argonne 2 will include a 12-week interim analysis, which we are targeting for mid-year 2021, to assess that balance and to generate dose information more quickly for potential combinations with other mechanisms in NASS. We are additionally developing EDP-297, our follow-on FXR agonist candidate. We're pleased to be on track to initiate a phase one study of EDP-297 later this quarter and expect data in the second quarter of 2021. We're excited about ADP297, given compelling preclinical data that demonstrate its high potency and tissue targeting characteristics compared to other FSR agonists in development. Specifically, ADP-297 is targeted to tissues important for efficacy, namely liver and intestine versus plasma and skin. We believe that a highly potent, highly selective, and tissue-targeted FXR agonist may allow for lower effective doses and an improved tolerability profile.

Are going to will include a 12 week interim analysis, which we are targeting for mid year 2021 to assess the that balance and to generate dose information more quickly for potential combinations with other mechanisms and Nash.

We are additionally, developing ATP to loan seven or follow on FXR agonist candidate for Nash, we're pleased to be on track to initiate a phase one study of GDP to nine seven later this quarter and expect data in the second quarter of 2021.

We're excited about GBP 297, given compelling preclinical data that demonstrated high potency and tissue targeting characteristics compared to other affects our arguments from development.

Specifically eating grew to nine seven was is targeted to Cushing is important for efficacy, namely liberman testim versus plasma on skin.

We believe that a highly potent highly selective and tissue targeted FXR agonists.

Now for a lower effective doses on on improved Tolerability profile.

We plan to present, two posters on the preclinical profile of GDP to nine seven at needle at useful later this month.

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

We look forward to moving our HPV trial and by remit patients forward with preliminary data anticipated in the first half from 2021.

We also look forward to preliminary results from our phase one trial on HBV patients, who are nuke suppressed by the second quarter of the year.

Jay R. Luly: We plan to present two posters on the preclinical profile of EDP-297 at EADL and EASL later this month. I'd like to conclude my remarks by emphasizing a few key takeaways. We look forward to moving our HPV trial and viremic patients forward with preliminary data anticipated in the first half of 2021. We also look forward to preliminary results from our Phase 1b trial on HPV patients who are nuked suppressed in the second quarter of the year. We are pleased that the RSVP trial is continuing in the Southern Hemisphere, and we are ready to return to sites in North America while adding additional sites in Europe during the coming fall and winter RSVPs.

We are pleased that the RSVP trial has continuing in the southern hemisphere, we're ready to return to sites in North America, while adding an additional sites in Europe during the coming fall and winter RSV season.

We're also eager to begin our two other RSV studies, when both pediatric patients and adult transplant patients next quarter.

And finally, we are excited about advancing our candidates announced where we were able to initiate the earned on T trial of GDP Threeo five and are on track to initiate a phase one study of GDP to nine seven them this quarter.

I'll stop here in turn the call over to Paul to discuss our financials for the quarter Paul.

Thank you Jay I'd like to remind everyone that an answer reports on the September thirtyth fiscal year schedule.

Today, we are reporting results for our third fiscal quarter ended June Thirtyth 2020.

Jay R. Luly: We're also eager to begin our two other RSV studies in both pediatric patients and adult transplant patients next quarter. And finally, we're excited about advancing our candidates in NASH, where we were able to initiate the Argonne II trial of EDP-305 and are on track to initiate the Phase I study of EDP-297 this quarter. I'll stop here and turn the call over to Paul to discuss our financials for the quarter.

For the quarter total revenue was 18.7 million and consisted entirely of royalty revenue earned on Abbvies Global TCV net sales of 376 million.

This compares to total revenue of 44.4 million to the same period in 2019.

The decrease in royalty revenue is a result of Abbvies lower net sales, which were significantly affected worldwide by the decline in patient volumes due to the Covance 19 pandemic.

Paul J. Mellett: 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 third fiscal quarter ending June 30, 2020. For the quarter, total revenue was $18.7 million and consisted entirely of royalty revenue earned on AbbVie's global HCV net sales of $376 million. This compares to total revenue of $44.4 million for the same period in 2019. The decrease in royalty revenue is a result of AbbVie's lower net sales, which were significantly affected worldwide by the decline in patient volumes due to the COVID-19 pandemic. Abby now expects HCV sales of approximately $2.1 billion for calendar year 2020, as treatments remain below pre-COVID levels. Royalty revenue was calculated on 50% of Maverick sales at a royalty rate of 10% after adjustments for certain contractual discounts, rebates, and setoffs, which are now just over 2% of AVI's total reported HCV sales.

Abby now expects HCV sales of approximately $2.1 billion to calendar year 2020, as treatments remain below pre covance levels.

Royalty revenue was calculated on 50% of marriage sales at royalty rate of 10% after adjustments for certain contractual discounts rebates and set us which are now just over 2% of have these total reported HCV sales.

I'll remind everyone that our royalties, which are calculated separately for each product are determined on a calendar year basis for a tiered schedule of rising royalty rates the royalty schedule restarted at our lowest royalty rate of 10% in our quarter ending March 31.

This means that royalties in the same amount of quarterly marriage sales would typically increase each quarter with our royalties for the quarter ending December 30, onest, having the highest blended royalty rate.

You can review our royalty tier schedule in our 2019 form 10-K.

Moving onto our expenses for the three months ended June Thirtyth 2020 research and development expenses totaled 34.7 million compared to 34.5 million for the same period in 2019.

General and administrative expense for the quarter was 6.8 million compared to 6.2 million for the same period in 2019.

Paul J. Mellett: I'll remind everyone that our royalties, which are calculated separately for each product, are determined on a calendar year basis through a tiered schedule of rising royalty rates. The royalty schedule restarted at our lowest royalty rate of 10% in our quarter ending March 31. This means that royalties in the same amount of quarterly marriage sales would typically increase each quarter, with our royalties for the quarter ending December 31st having the highest blended royalty rate. You can review our royalty tier schedule in our 2019 Form 10-K. Moving on to our expenses, for the three months ended June 30, 2020, research and development expenses totaled $34.7 million, compared to $34.5 million for the same period in 2019. General and Administrative Expense for the quarter was $6.8 million, compared to $6.2 million for the same period in 2019. This increase is due to an increase in compensation expense for the quarter.

This increase is due to an increase in compensation expense for the quarter.

And into recorded an income tax benefit of 7.1 million for the three months ended June Thirtyth 2020, compared to an income tax benefit of point 9 million for the same period in 2019.

The income tax benefit for the quarter was driven by our net loss for the period Federal research and development tax credits and a federal net operating loss carry back.

And it is effective tax rate for the nine months ended June Thirtyth 2020 was approximately 58% compared to less than 1% for the same period in 2019.

The effective tax rate for 2020 reflects increasing federal research and development tax credits and a federal net operating loss carry back.

Net loss for the three months ended June Thirtyth, 2020 was 14.3 million or a loss of 71 cents per diluted common share compared to net income of 7 million or 33 cents per diluted common share for the corresponding period in 2019.

Paul J. Mellett: Enanta recorded an income tax benefit of $7.1 million for the three months ending June 30, 2020, compared to an income tax benefit of $0.9 million for the same period in 2019. The income tax benefit for the quarter was driven by our net loss for the period, federal research and development tax credits, and a federal net operating loss carryback. Enanta's effective tax rate for the nine months ended June 30, 2020 was approximately 58% compared to less than 1% for the same period in 2019. The effective tax rate for 2020 reflects increasing federal research and development tax credits and a federal net operating loss carryback. The net loss for the three months ended June 30, 2020 was $14.3 million, or a loss of $0.71 per diluted common share, compared to net income of $7 million, or $0.33 per diluted common share, for the corresponding period in 2019. Enanta ended the quarter with approximately $435 million in cash and marketable securities, an increase of approximately $35 million from our 2019 fiscal year-end balance of $400.2 million.

And then to ended the quarter with approximately 435 million in cash and marketable securities an increase of approximately 35 billion from our 2019 fiscal yearend balance of 400.2 million.

We expect that these cash resources as well as our continuing royalty revenue will continue to be sufficient to meet our anticipated cash requirements for the foreseeable future.

Further financial details are available in our press release and will be available on our form 10-Q for the quarter when filed.

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

Q asking question you any depressed star one on your telephone I will address your question press the pound team. Please standby will become Albuquerque Monday roster.

Your first question comes from Eric Joseph with Jpmorgan.

Hi, guys. Thanks for taking my question.

Just a couple of from US first on it achieved five one for.

Jim just wondering if you should sort of frame expectations for us.

In the phase one the in new SPRIX nuke suppressed patients with data expected the second quarter.

How.

Should we be thinking about.

Yeah.

Data that would be establishing a go forward dose regimen, there and what.

Compelling results would look like in terms of.

Operator: We expect that these cash resources, as well as our continuing royalty revenue, will continue to be sufficient to meet our anticipated cash requirements for the foreseeable future. Further financial details are available in our press release and will be available on our Form 10-Q for the Quarter 1 file. I'd now like to turn the call back to the operator and open up the line for questions. Operator? To ask a question, you will need to press star 1 on your telephone.

Barrels.

Well you started yet what the objective there are in terms of us out of your go forward dosing in that that's great. Thanks.

Sure. Thanks, Eric This is so this is Craig.

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So you have that the nuke suppressed study is.

As one of the two that we have going on right now.

Why don't I, just actually compare and contrast, a little bit as as I answered. The question. So you get a flavor for both studies.

Operator: To withdraw your question, press the pound key. Please stand by while we compile the Q&A. Your first question comes from Eric Joseph with J.P. Morgan. Hi guys, thanks for taking the questions. Just a couple from us first on EDT 514.

They are both 28 days studies.

But there are quite different the new expressed folks are obviously.

On a.

An existing nuclear therapy, so, they're DNA and levels are already going to be quite suppressed.

They are both as I mentioned 28 days studies. So what you can get out of the nuke suppress study that's.

Eric William Joseph: Jay, I'm just wondering if you can sort of frame expectations for us in phase one, the in nuke suppressed patients with data expected in the second quarter. How should we be thinking about data that would be establishing a go-forward dose regimen there, and what compelling results would look like in terms of virals. Well, sorry, yeah, what the objectives there are in terms of establishing a go-forward dose in that study. Thanks. Sure. Thanks, Eric. So this is Jay.

Extremely important it's actually safety and Tolerability and PK in that context of a new as you know.

Nukes or the sort of the standard of care.

Today for Hep B treatment and.

The study substantially is looking to make sure that 504 play as well with new so.

Thats the domain name of this study will of course also good other anti viral.

Jay R. Luly: So, yeah, the nukes suppressed. That study is one of the two that we have going on right now, and why don't I just actually compare and contrast a little bit as I answer the questions so you get a flavor for both studies. They're both 28-day studies, but they're quite different.

Data from this.

On a.

Thats antigen E antigen and permission but.

Not to expect too much there given the.

The 28.

Nick 28 day nature of the.

Jay R. Luly: The nuke-suppressed folks are obviously on an existing nuclear therapy, so their DNA levels are already going to be quite suppressed. They're both, as I mentioned, 28-day studies. So what you can get out of the new suppressed study that's This study is substantially looking to make sure that 514, you know, plays well with nukes. So that's the main aim of this study. We'll, of course, also get other antiviral data from this, you know, RNA, that's antigen information, but not to expect too much there, given the 28-day nature of the study. In the case of the viremic study, it's a little bit different. So we'll be, again, it's a 28 day study; we'll be looking at patients who haven't been on HPV therapy for at least a year and who have significantly elevated DNA levels.

Of this study.

In the.

In the case of the Viremia study, it's a little bit different so we will be.

Again, it's a 28 days study will be looking patients.

Who havent spent on HPV.

Therapy for at least two year.

And who have significantly elevated.

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DNA and levels, so quite a different patient population in there.

Again will be dose ranging too.

Yeah look for.

Again safety Tolerability PK.

With the drug alone in that case, but also we'll be looking at.

At biologic parameters.

As well, so DNA, we'll be able to get.

Our in a.

Antigen E antigen, and so forth, but it's really over.

28 day.

Time period.

Jay R. Luly: So, quite a different patient population. And there, again, will be dose ranging to look for, again, safety, tolerability, PK with the drug alone in that case, but also we'll be looking at virologic parameters, as well. So DNA will be able to get RNA, S-antigen, E-antigen, and so forth.

In terms of.

Some sort of a range of what we would like to see in that by remix Saudi I'd say.

Something that would give us.

Solid.

To log decrease or more over that time period would be I think give us a sense the tribe form fours working.

Working well, so we'll be using all that information together to pick.

Going forward.

Jay R. Luly: But it's really over a 28 day time period, in terms of some sort of range of what we would like to see in that biuremic study, I'd say something that would give us, you know, a solid two log decrease or more over that time period would give us a sense that 514 is working. Working well. So we'll be using all that information together to pick, you know, go forward, Joseph. Great. Thanks for taking the questions. Thank you. Your next question is from Brian Snorski with. Hey, good afternoon, guys.

Yes.

Great. Thanks for taking my questions.

Q.

Your next question is from Brian This norske with Baird.

Hey, good afternoon, guys. Thanks for taking my question.

Just wondering sort of thing about the argon trial design and post wondering debt that data.

End of your thoughts on how you think about kind of phase three and and what the regulatory hurdle is here, Matt we've all seen.

Alexia into the first products are agonist going to rejection by the.

Although seemingly headache, what's within the FDA guidance just.

Jay R. Luly: Thanks for taking the question. Just when we sort of think about the Argonne trial design and when we get that data, you know, kind of your thoughts on how you think about phase three and what the regulatory hurdle is here. I mean, we've all seen OCA, the first FXR agonist, get a rejection by the FDA, although seemingly hitting what's within the FDA guidance. Interested in getting your thoughts, Jay, on your view of that outcome and, you know, how we should be thinking about the development of FXR for U.S. approval in the future. Sure, so... Well, I think, I think the community at large, you know, the KOLs and, and certainly Wall Street.

Interested in getting the thoughts Jay on.

Your view of that outcome and.

How we should be thinking about the development of our FX are.

For a U.S. approval on the future Max.

Sure so.

Well I think I think the community at large.

I think Kale wells.

And certainly wall Street and some have.

Intercepts competitors were actually all sort of surprised to see the complete response letter there.

So I think we just need and regarding phase three studies.

I think we just need to see.

More information try to understand a little bit better.

What the FDA had mind with regards to intercept package.

Jay R. Luly: Some of Intercept's competitors were actually all sort of surprised to see the complete response that there is. So I think we just need, regarding phase three studies, I think we just need to see more information, try to understand a little bit better what the FDA had in mind with regard to Intercept's package, and Intercept, I understand, is having some meetings with the agencies. So over time, I think we'll get greater transparency as to what's going on. [inaudible] You know, our path is pretty straightforward.

Intercept I understand is having some meetings with the agencies so.

Overtime, I think we will get.

Greater transparency as to what's.

Going on there what's happened there and what may only in the future for intercept EMCORE others. So it's a sort of a broad ranging question.

That will just need to see how it plays out but it's.

Certainly very intriguing.

Element to say the lease for us.

Our our path is pretty straight forward.

We're not in the middle or even starting a registration study at this point so to the extent Rooney goal posts that could move around a little bit or other ways that the.

Jay R. Luly: You know, we're not in the middle or even starting a registration study at this point. So, to the extent there are any goalposts that could move around a little bit or other ways that the regulatory path could be impacted here, you know, we'll have plenty of time to process that, and incorporate it into future studies. So for us, for the Argonne study, Argonne, too. As you know, it's really about staring between the goalposts of doses that we looked at in ARGON1. We're bumping up the low dose, we're bringing down the top dose, and we know exactly what to look for vis-a-vis target engagement and also tolerability. So that's a fine-tuning of the dose selection there. And again, we'll have an interim analysis that'll come along sort of mid-next year where we'll have a pretty good sense of how those two doses behave and will give us good guidance for the future. And then separately, you didn't ask about 297, but it's also a molecule in the same class. It's tucking along very nicely, you know, on a parallel path.

Regulatory path could be impacted here.

And we'll have plenty of time to process that incorporated on Q.

Future studies.

So for for Us for the Oregon study.

Argon too.

As you know it's really about.

Staring between.

Goalpost doses that we looked at in in Oregon One.

We're bumping up the low dose, we're bringing down the top dose.

And we know exactly what to look for vis-a-vis.

Target engagement.

And also tolerability. So that's a fine tuning of of a dose selection there.

And again, we'll have an interim analysis that will.

Come along.

Sort of mid next year will have.

A.

Pretty good sense of how those two doses behaved and we will give us good guidance for the future and then separately.

You didn't ask about 297, but.

Also.

The molecule of the same class.

It's a tuck in along very nicely.

And on a parallel path.

Enter.

Jay R. Luly: And our plan is to get that into phase one this quarter and then to, you know, look at the parameters that we know how to measure well, first in healthy people, where we can look both at target engagement and tolerability, and then... understand whether the thesis that we've generated in terms of the design of the follow-on FXR agent plays out in the clinic. So that'll be exciting to watch, too, over the course of the next few quarters, and we expect data on that 297 molecule in the second quarter of next year. Great, thanks. You're welcome. Your next question is from Rory Buchanan with J&P Security. Hi, great. Thanks for taking the time to answer the question. I had a handful on RSV. I was wondering if you'd give us some details for RSVP, how the Southern Hemisphere RSV season is looking. And can you tell us how many sites you're targeting for Europe?

Our plan is to get that into phase one this quarter.

And then to.

Sarah the at the parameters that we know how to how to measure well first and Healthys, where we can look both at target engagement and Tolerability.

And then.

I understand whether the thesis that weve generated in terms of the design of the follow on FX our agent plays out.

In the clinic so.

That will be exciting to watch to over the course of the next few quarters and we expect data on on that to nine seven molecule in the second quarter next year.

Great. Thanks.

You're welcome.

Your next question is from Roy Buchanan with JMP Securities.

Hi, great. Thanks for taking the questions that a handful of ours. The I'm just wondering if you give us.

Some details for our CPR the southern Hemisphere RSV season is looking at I can tell us how many targets how many sites you are targeting for Europe.

Jay R. Luly: And then I had a couple of questions on the phase two trials you're planning in pediatrics and transplant patients. Are those going to be solely based in the U.S.? I have one follow-on question. So, with regard to RSVP in the Southern Hemisphere, you know, it's just, winter is just kicking in. Um, you know, it's going to be really interesting to see how the Southern Hemisphere plays out. It's a little bit of a different setting. You know, Australia and New Zealand opened up reasonably early after being, you know, locked down for a while, so they were opening up. But that said, one of the things that was It's interesting, as we're watching the flu numbers, and the flu season is coming late in the Southern Hemisphere. So the question is, you know, did all the social distancing and the lockdown and the, you know, sort of, they had a severe sort of travel ban that blocked what would otherwise be a lot of Northern Hemisphere people from coming down to the Southern Hemisphere right before their winter season.

Had a couple on the phase two trials are plenty in pediatrics and the transplant patients where are those going to be solely based on the us.

I have one follow up.

So with regards to RSVP in the southern Hemisphere. It's just winter is just kicking up.

It's going to be really interesting to see how southern hemisphere plays out it's a little bit.

Okay different.

Setting.

In Australia, New Zealand.

Opened up.

Reasonably early.

Early after being locked down for awhile. So they were opening up.

But that said.

One of the things that wins.

Well, it's interesting as we're watching the flu numbers and the flu.

Season is coming late.

In the southern Hemisphere. So the question is.

To be all the social distancing and the locked down and the sort of.

It had a severe sort of travel ban that blocked what would otherwise be a lot of northern hemisphere people from coming down to the southern hemisphere right before their winter season. So they were able to kind of go to school on what was happening on the northern Hemisphere takes one of the best practices and start prevention down lower early.

Jay R. Luly: So they were able to kind of go to school on what was happening in the Northern Hemisphere, take some of the best practices, and start prevention down there early. So what we'll have to wait and see is, you know, as things open back up, and they have been for several weeks now, and as they slide into winter, which they're doing right now, will it simply be a frame shift of a sort of normal cold and flu season and RSV season? Or will it be, you know, somehow blunted a little bit?

And so what will have to wait and see is.

As things open backpack and they have been for several weeks now and as the slide into winter, which they are doing right now.

Well it simply be a frame shift.

Hey.

Sort of a normal cold and flu season, and RSV season or will be will it be.

Somehow blunted, a little bit and.

Jay R. Luly: And, you know, we obviously can't know the answer to that. We'll have to wait and see how it plays out over the next few months. But, you know, we sort of anticipated that a little bit earlier this year when we were doing our planning, which is why we, you know, plan to come back up to the Northern Hemisphere, where we have dozens and dozens of sites already set up in North America and where we'll be adding sites in Europe. So I think, I think we're anticipating, you know, all toll with the US, Canada, and Europe, I You know, we're also thinking about further mitigation, whether or not we even consider strapping on Asian countries, as might be, you know, appropriate.

We obviously can't know the answer to that left the wait and see how it plays out over the next month.

Boat, we sort of anticipated up a little bit earlier this year, when we were doing our planning which is why we.

Plan to come back up to the northern Hemisphere, where we have dozens and dozens of sites already set up in North America.

And to where we'll be.

Adding.

Sites in Europe. So I think I think we're anticipating you know all told what the US Canada and Europe I think we'll have over 100 sites on that order.

And.

We're also thinking about further mitigation.

Whether or not we even consider strapping on Asia countries.

As might be.

Appropriate so the team has done a.

Jay R. Luly: So the team's done a great job at sort of, you know, it's a little bit of a wild ride on respiratory viruses these days. But I think we're well-poised, well-positioned, and... have everything, including the testing equipment that we need to get the characterization done on the diagnosis. I'm, Then, I think you had a question on the peds. I was just curious. Yeah.

Great job it sort of.

Okay, so little bit of wild ride on respiratory.

Hi viruses.

These days, but I think Paul.

We are well poised well position.

Yeah.

Hello, everything, including the testing equipment that we need to get the characterization done on the diagnostic Trump.

The I think you had a question on the peak.

Does that just curious it yet.

Great.

Yes, no that was perfect.

Jay R. Luly: Yeah. Yeah. No, that was perfect.

That the pediatric transplant trials I was wondering if there was going to be fully us based trials.

Jay R. Luly: The pediatric and the transplant trials, I was wondering if those are going to be solely U.S.-based trials. So we'll be starting in the Northern Hemisphere.

So we'll.

We'll be starting in the.

In the northern Hemisphere.

Jay R. Luly: But ultimately, we'll be adding on, you know, other AQS sites as well. And then I actually had a follow-up, and you kind of answered it with your, I think, a Southern Hemisphere answer, but the RSVC, even in the U.S., this last year kind of dropped off quickly, and I was wondering if that was possibly people getting tested for COVID and not following up when it was negative, or the social distancing, reducing the bystander effect? It actually, you You know, that was the really surprising thing.

But ultimately we'll be adding on.

Other ex us sites as well.

Okay, Great and then how to actually had a follow up the kind of answered it what's your I think what the southern hemisphere.

Answer, but the RSV season in the U.S. This last year kind of dropped off quickly and I was wondering if that was possibly people getting tested for covanta not following up when it was negative or the social distancing reducing the.

Andrew effects.

Okay that actually had sort of common gone before covert was a word.

You know that was that really surprising thing usually RSV.

Jay R. Luly: Usually, RSV in the Northern Hemisphere peaking in the January, February timeframe, you know, sliding through March and maybe tailing into Q2. That's sort of the typical presentation. And, you know, for whatever reason, this last year was very strange. It peaked in December and then fell very quickly.

In the northern Hemisphere is peaking animal January February timeframe.

Sliding through March and May be tailing into Q2, that's sort of the typical presentation and.

For whatever reason.

This last year was very strange that the peaked in December.

On on among share shell very quickly.

Jay R. Luly: So, and unexpectedly, so, Um, I think that's a you know, hopefully. Unknown Speaker 08.01.2013 Page PAGE of NUMPAGES www.verbalink.com Page PAGE of NUMPAGES, The RSVP study was up and running as fast as we could after data just by the end of the year. Figuring out the January-February end to Q2 would be the big period, but it was pretty much fun. This time, we still have all the sites that we had before.

So and unexpectedly so.

I think that say.

Hopefully.

That's a bit of an anomaly, but either way.

The difference between this year and last year last year as you know we were just finishing up the challenge study and just getting the.

The.

SPP study up and running as fast as we could after data.

Just by the end of the year.

Figuring that January February and into Q2 would be the big big period, but.

Pretty much.

Pretty much fund this time.

We still have all the sites that we have before.

Weve.

Jay R. Luly: We've suggested we're supplementing that with a bunch of European sites and so forth. And then we'll get, you know, what we can down in the Southern Hemisphere. We'll just continue to watch it, but we're adding lots. Okay, great. Thanks for taking the questions. You're welcome. Your next question is from Brian Abrahams with RBC Capital Market. Hi, this is Leo on behalf of Brian.

We have suggested were supplementing that with fall into European sites and so forth.

And well known we'll we'll get.

What we can Donald Lu from a set of demonstrate so.

Well just.

Continue to watch it we're we're adding lots of sites.

Okay, great. Thanks for taking the questions.

You're welcome.

Your next question is from Brian Abrahams with RBC capital markets.

Hi.

This is lee on for Brian Thanks for taking my question.

Operator: Thanks for taking my question. I have one on the human pneumonia virus. So you guys have hinted at some of the leads you've identified.

I have one on the human pneumonia virus so.

So you guys have hinted at some of the lead you've identified can you remind us what the timelines are for this program to enter the clinic and perhaps what the ultimate opportunity for this program and how much work is going to need to be done to educate physicians and patients about this this respiratory virus and I guess will there be interested if any synergy.

Operator: Can you remind us what the timelines are for this program to enter the clinic and perhaps what the ultimate opportunity you see for this program and how much work is going to need to be done to educate physicians and patients about this respiratory virus? And, I guess, will there be any synergy with the RSV program there? So, you know, thanks for the question. It's, I was wondering if the human virus would be picked up as a topic. It should be like this.

With the RSV program there.

Okay.

So.

Thanks for the question its.

I was wondering if implemented buyers would be picked up as a as a topic it should be.

Jay R. Luly: You know, everybody is certainly aware of RSV and sort of the threat that it represents to a number of different patient populations, you know, preying on the young and the old, the immune compromised, and so forth. And in some years, RSV, you know, can be a big season, sort of rivaling some of the in some patient populations, what True does. Human metanumo is sort of the second leading cause of everything that RSV causes. It hits the same patient populations for the most part. Patients have pretty much the same presentation and the same sort of patient journey. It starts with an upper airway disease and can migrate to a lower airway disease. You can get pulmonary inflammation, cytokine storms, and so on. And I think it's a little bit less known because it was sort of first characterized about 20 years ago.

The reason everybody.

It's certainly aware of RSV and sort of the.

Threat that it represents to a number of different patient populations preying on the young from the old immune compromised and so forth.

And in some years RSV.

You know can be a big season sort of rivaling some of the in some patient populations what two dogs.

Human met a new motto is sort of the second leading cause of everything that RSV.

Causes.

It hits the same patient populations for the most part.

Patients have pretty much the same presentation in the same pace sort of patient journey starts and the number airway disease can migrate to a lower or way disease you can get.

Pulmonary information cytokines storms, and so on and I.

I think it's a little bit less known because it was sort of first characterize about 20 years ago and.

But if you hang out at the respiratory infection meetings, you actually see a lot of human metal newmont, there. So the medical community of people who treat.

Jay R. Luly: And if you hang out at the respiratory infection meetings, you actually see a lot of human metanuos there. So, the medical community, people who treat patients, are quite aware of this virus. And so, I think it's the, you know, relative, fact that it's relatively new and that, you know, there hasn't been sort of a new approach coming into human respiratory viruses lately until, you know, sort of EDP 938. And David. I think there's going to be a whole lot more attention to human respiratory viruses. People are going to get these things, and you can quickly rule out the flu; you can, by testing, you can now rule out COVID.

Patients.

Our quite aware of this virus.

And so I think it's the.

Relative to the fact that it's relatively new and that.

Others, Havent hasn't been sort of a new approach coming into.

Human respiratory viruses.

Lately until sort of interest.

Needy BDP 938.

Came along.

You know sertich in a different approach than what people have done.

RSV with small molecules that I think there's going to be now and then add kogut on top of that just a whole lot more attention to human respiratory viruses people are going to get these things and you can quickly sort of rule out flu.

You can buy testing you can now roulette coven, so when people come in and they present and they're getting tested it's going to be will what do they have then and I.

Jay R. Luly: And so when people come in and they present, and they're getting tested, it's going to be, well, what do they have then? And I think with the increased awareness of seeking, seeking, speaking of medical care when you have symptoms, getting diagnosed, and then getting tested, it lends itself to being sort of a portfolio of approaches that we're thinking of with human respiratory viruses.

I think with the increased awareness.

Seeking.

Seeking.

Sure.

Seeking medical.

Care when you have sometimes getting diagnosed and then getting tested I think there that lends itself to being sort of a portfolio of approaches that we're thinking of with human respiratory buyers. So.

Jay R. Luly: So, we obviously weren't thinking of COVID when we started on human meta-pneumo some time ago. What we were thinking of was it was a perfect sort of adjacency if you think of it from a commercial perspective, when you're building out a business on human respiratory viruses. If you're working on RSV, it makes an extraordinary amount of sense to be working on human meta-pneumovirus because, again, people are going to get diagnosed, and if it's one, you get one Enanta drug.

We we obviously weren't thinking of covert when we started on human met a new more.

Sometime back.

What we were thinking of it was it was a perfect sort of adjacency. If you think about it from a commercial perspective, if you are building out of business on human respiratory viruses.

If you're working on RSV.

That makes an extraordinary amount of sense to be working on human medicine room of ours, because again people are going to get diagnose.

And if there if it's one that you get.

I want to announce a drug if thats another we get another and antidrug and I think the.

Jay R. Luly: If it's another Enanta drug, you get another Enanta drug. And I think the only other company that's sort of really thinking about it that way is probably Moderna, although they're trying to take a vaccine approach, obviously. Many people have tried vaccines on RSV for many, many years, but they have failed. And so, what we hope to do is really come forward with, you know, a new drug class for a new treatment therapy where no treatments exist today and where no vaccines have succeeded yet. So, the human meta-pneumo makes a lot of sense.

I think the only other company that's sort of really.

Thinking about it that way is probably moderna, although they are trying to ticket vaccine approach obviously.

Many people have tried that teams on on the RSV for many many years.

On successfully and so what we hope to do is really come forward with.

New drug class for a new all treatment therapy, where no treatments exists today and where no vaccines have succeeded today. So.

Human met a new will makes a lot a sense now where are we.

Jay R. Luly: Now, where are we? It's a drug discovery program. We announced it in January at J.P. Morgan.

It's a drug discovery program, we announced stood in January at JP Morgan.

We've got Nanomolar molecules that we like a lot. So I would say we're in the Apple polishing stage and.

Jay R. Luly: We've got nanomolar molecules that we like a lot, so I would say we're in the apple polishing stage, and the trick is doing what Enanta does pretty well and has done lots of times before, which is taking a really potent, interesting lead with strong virology and then optimizing all the other characteristics that you need to have a very successful clinical candidate. So it's at that interface now, and hopefully we'll have something before too long, but again, we gotta check all of the boxes that we're checking. But I think it makes, again, a terrific amount of sense.

The trick is doing with financing does pretty well and has done lots of times before which is.

Taking a really potent interesting lead with strong by raw energy and then optimizing all the other characteristics that you need to have.

A very successful clinical candidates. So it said that interface now and.

Hopefully hopefully we'll have from something before too long, but again, we've got to check all of the boxes that were that we're doing but I think it.

Mix again, a terrific amount of sense perfect complement to our other program.

Jay R. Luly: It's a perfect complement to our other program. Thank you. You're welcome. And as a reminder, ladies and gentlemen, if you would like to ask a question at this time, simply press star, then the number one on your telephone keypad. Your next question is from Jay Olson. Oh, hi.

Thank you.

Welcome.

And as a reminder, ladies and gentlemen, if you would like to ask your question at this time simply press Star then the number one on your telephone keypad.

Your next question is from Jay Olson with Oppenheimer.

Jay Olson: Thank you for taking the question. I'm curious about the work you're doing on SARS-CoV-2, and I'm wondering if there's any recent research on the virus itself or any of the work that's been published on therapeutic antibodies or vaccines that has informed your discovery efforts for a DAA, and then maybe if you could comment on how close you are to nominating a candidate. Thank you. Sure. Thanks, Jay, for the question. So I'd say, you know, there are, mercifully, a lot of folks in the world trying to attack this problem. You know, let's all hope that vaccines are successful and can treat as many or prevent as many people as humanly possible. I'd say the vaccine approach is something that hasn't really informed our strategy, you know, at all.

Hi, Thank you for taking the question I'm curious about the work you're doing on Sars Koby too and I'm wondering if there's any recent research on the virus itself for any of the work. That's been published on therapeutic antibodies are vaccines that has informs your discovery efforts for.

Da and then maybe if you could comment on how close you are to nominating Kennedy. Thank you.

Terrific. Thanks, Jay for the question. So I'd say you know there's.

Most of fleet or a lot of folks in the world.

Trying to attack this problem.

And.

Let's all hope that vaccines are successful and can treat as many urban prophylaxis many people as humanly possible.

I'd say the vaccine approach is something that.

Hasn't really informed our strategy.

At all I know people, whether its antibodies are vaccines or or thinking about spike proteins and other sorts of targets to to generate.

Jay R. Luly: I know people, whether it's antibodies or vaccines or thinking about spike proteins and other sorts of targets to generate, [inaudible] Some other folks are doing out there, but it's very consistent if you've been following the thread on our respiratory viral programs with our approaches there. And that is, we assume, that vaccine, no vaccine, partially effective vaccine, or not, or, you know, some compliance, but not total compliance. There's always gonna be people with infections, assuming that SARS-CoV-2 doesn't burn out. And right now, that doesn't seem as likely as people had once hoped.

Interesting biologics.

We're we're doing is.

Something that's.

On the one hand, it's a bit different from what.

Some other folks are doing out there, but it's very consistent if you've been following the thread on on our respiratory viral programs with with our approaches there and that is.

We assume.

The vaccine no vaccine partially effective vaccine.

Or not.

Or.

Some compliance spend on total compliance theres always going to be people with infections, assuming that Sars coke to doesn't burn out.

Right now.

That doesn't seem as likely as people had once hope so if you put yourself into that box and we think.

Jay R. Luly: So if you put yourself into that box and think, you know, a few years from now, there could still be, even with vaccines around, a lot of important need for therapeutics and going after them in a very targeted way. So, you know, imagine if we could ever get to a state where we treat people like we do in our RSVP trial, where people walk in, they present at a clinic, they're symptomatic, and they get tested with an RT-PCR assay. It's determined that they have COVID or RSV or human metapneumo. And then they get put on a direct-acting antiviral, which can fairly rapidly, if other viruses, other respiratory viruses are some signal of this, you ought to be able to fairly rapidly knock that viral load down and then hopefully change the course of the person's infection.

A few years from now there could still well be even with vaccines around.

A lot of important.

Need to score.

Therapeutics and going after them in a very targeted way so imagine if we could ever get to a state where we're treating people like we are in our RSVP trial, where people walk in the presented a clinic.

There is symptomatic they get tested with an RT PCR assay, it's determined that they have co bid or RSV or human metal pneumo.

And then.

They get put on a direct acting antiviral, which Ken.

Fairly rapidly if.

If other viruses other respiratory viruses are some signal of this you ought to be able to fairly rapidly not that viral load down and then hopefully.

I'm change the course of the person some correction and that's kind of the exciting things weve.

Jay R. Luly: And that's one of the exciting things we've shown with RSV is that from the time we put people on the drug, within 24 hours, it really alters the course of the infection. That's what our challenge study showed. So if we can do that with COVID, you know, people can go home, people won't be, you know, spreading, turning into super spreaders, they won't be infecting their family and relatives, and hopefully, within a few days, they can go back to work. So that's where we're aiming. Again, it's not a vaccine, it's not a sort of antibody treatment where you're going to have to go into the body and then infuse it or otherwise, you know, treat somebody who's very symptomatic with the biologic.

Shown with ours me was up from the time, we put people on the drug.

Within 24 hours, it's really altered the course of the of the infection Thats what our challenge study shows so if we can do that with Covance.

People can go home.

People won't be.

Spreading turning into Super Spreaders, they won't be reflecting their family and relative to some hopefully within a few days.

They can go back to work, so that's where we're aiming.

Again, it's not acquire it's not a vaccine it's not a sort of an antibody.

Treatment, where you're going to have to go into and fuse that or otherwise.

Treat somebody.

So a very symptomatic with the biologics.

Jay R. Luly: What we want to do is, you know, go early, hit hard with an oral regimen, and knock it down. And think that that's going to be, if you follow where this is all going, it could well be an incredibly important opportunity out there that's not receiving as much attention as the vaccine. That's very helpful. Thank you, Jay. You're welcome. You're next. From Akash Tiwari with, Hi, this is Amy Lee-Unther Koch.

What we want to do as you know go early hit hard with an oral grossman and knock it down and.

And think that thats going to be if you follow where this is all going it could well be at an incredibly important.

And.

Opportunity out there.

That's not not receiving has as much.

Additionally, his thoughts in square mall.

That's very helpful. Thank you Jay.

Welcome.

Your next question is from Castellari with Wolfe research.

Hi, this is aiming the unfair costing demands for taking your question.

Amy Li: Thanks so much for taking our questions. We just had a couple on your RCP program. First, on your powering in RCP, can you go over your assumptions in general and how you accounted for the differences in time to administration between the Phase 2a and Phase 2b, given that patients in Phase 2b will likely be administered the drug later in the course of disease? Also, will your powering allow you to properly stratify for baseline factors and endpoints such as time to symptom onset, baseline viral titer, different cuts of symptom And then, in regards to the pediatric and adult HSCT RCP trials, will you also have a 48-hour symptom cutoff like RCP, and what types of clinical endpoints will you be evaluating in these studies? Anything you can share on the design would be very helpful.

A couple on your R&D program first on your how are you RCP can you go will be your assumptions in general and how you conference or the different.

Hi, Jim integration between the phase 288 to be given that patients a day to be will likely be minister directly into the course of disease also will your powering allow you to properly stratify for baseline softer than unclaimed such as pontificate on sound based on vinyl tied are different but sometimes anesthetic better off I'm down in regards to the pediatric and adult HFC tea.

The trial will you also have a 48 hour symptom come up with RCP and what type of clinical endpoints would you be evaluating Andy study I think you can share on the design would be would be very helpful. Thank you.

Jay R. Luly: Thank you. I'm sorry. Anything to share on the design of the peds or transplant? Yeah. Is that what you said?

Im sorry, Sheridan anything to share on the design of the Pieds or transplant.

Yes that we've said, yes so.

Jay R. Luly: Yeah, I'll start with that question. First, I'm not sure we'll be able to dive in and tell the different, powering discussions. Right now, my biostatisticians aren't... with an immediate reach right now. But trust that the biostatisticians have powered this in a way that you know, look very carefully at, the challenge study made further assumptions as it related to, you know, an outpatient study where we would be looking at somebody 48 hours, within 48 hours of symptoms, and they powered the study accordingly, according to those parameters. In terms of the PEDS study, Again, we're going to be looking at hospitalized or non-hospitalized infants and children who are 28 days to 24 months of age.

I'll start with that question.

First im not sure we'll be able to dive in and tell the difference.

Powering discussions.

Right now.

Biostatisticians aren't.

Within immediate reach right now, but trust that the buyout statisticians have power. This.

In a way that.

No look very carefully.

The challenge study you've made further assumptions as it related to.

And outpatient study, where we would be looking at somebody 48 hours within 48 hours at sometimes and powered the study accordingly.

According to those parameters.

In terms of the the.

PK study.

Again, we're going to be looking at hospitalized or non hospitalized.

Infants and children.

And to be 28 days to 24 months of age.

Jay R. Luly: You know, we'll be looking at safety, obviously, to the utmost, and PK, those will be the things we'll be looking at early on, and we'll also be, of course, getting virologic parameters as well. With regard to timing, as I recall, with the outpatient non-hospitalized subjects, we're gonna be looking within a 48-hour time period. And with regard to the hospitalized peds, I believe we've set a 72-hour time period. I'm looking over at the hematopoietic cell transplant, folks. Again, we're going to be recruiting people who have an acute RSV infection of the upper respiratory tract. We'll be looking to evaluate what the incidence is of lower respiratory tract complications, and we'll also have secondary endpoints in there of safety and PK, and we'll also be looking at virologic parameters. I think in that too, we'll be looking and transplanting to, for inclusion, people who are within three days of death. These folks obviously have a very compromised immune system and so... You know, their symptoms can be.

We'll be looking at.

Safety obviously.

The up most.

And PK.

Those will be the things we'll be looking at.

Early on and we will also be of course getting.

Virological parameters as well.

With regards to.

To timing.

As I recall with the the outpatient non hospitalized subjects were going to be looking within a 48 hour time period.

And with regards to the hospitalized.

Pieds.

I believe weve.

We've set a 72 hour.

Time period.

I'm looking over at the hematopoietic cell transplant.

Folks again, we're going to be recruiting.

People who have.

Acute RSV infection of the upper respiratory tract.

We'll be looking.

To evaluate.

What the incidences of lower respiratory tract complications and we'll also have.

Secondary endpoints and their safety and PK in malls we.

Jay R. Luly: Great, thank you. You're welcome. And therein are further details.

Looking at by Roger parameters as well.

Operator: And that concludes our first question. We will be back with a question and answer session at 3 p.m., and you can go ahead and sign off. And if you have any questions, please feel free to contact us. Again, this is a call to action. You can call 1-800-637-8233.

I think in that two will be booking and transplant too.

No for inclusion people, who are within three days of symptoms.

Okay, Great and these are my leaves these folks have obviously very compromised immune system and so.

They they are sometimes can be.

Quite persisted.

Great. Thank you.

You're welcome.

There are no further questions in queue at this time ill now turn the call back over to Ms. Jennifer.

Jennifer Viera: And we will see you next time. Thank you for this time. I'll now turn the call back over to Ms. Jennifer Viera. Thank you, everyone, for joining us this afternoon. If you have any additional questions, please feel free to give us a call in the office or email me. Thanks again. Have a good evening. This concludes today's conference call. Thank you for participating. You may now go,

Thank you everyone for joining us. This afternoon. If you have any additional questions. Please feel free to give us a call in the office or email me. Thanks again have a good evening.

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

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