Q4 2021 Enanta Pharmaceuticals Inc Earnings Call

Good afternoon, and welcome to <unk> Pharmaceuticals fiscal fourth quarter and year end 2021 financial results Conference call. At this time, all participants are in a listen only mode.

Operator: Good afternoon, and welcome to Enanta Pharmaceuticals' fiscal fourth quarter and year-end 2021 financial results conference call. At this time, all participants are in a 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 would now like to turn the call over to Jennifer Viera, Investor Relations. Please go ahead. Thank you, Operator, and thanks to everyone for joining us this afternoon. The news release with our fiscal fourth quarter and year-end financial results was issued this afternoon and is available on our website.

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

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

The news release with our fiscal fourth quarter and year end financial results was issued this afternoon and is available on our website on the call today is Dr. Jay <unk>, President and Chief Executive Officer, Paul Mellett, Our Chief Financial Officer, and other members of Anantha Senior management team before.

Jennifer Viera: 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 developments and results to differ materially from those statements.

Jennifer Viera: 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?

Again with our formal remarks, we want to remind you that we will be making forward looking statements, which may include our plans and expectations with respect to our research and development pipeline and financial projections, all of which involve certain assumptions and risks beyond our control that could cause our actual developments and results.

To differ materially from those statements.

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

Jay Luly: Thank you, Jennifer, and good afternoon, everyone. Reflecting on our fiscal 2021 year, I am proud of the exceptional advancements we've made across our entire portfolio. By leveraging our years of drug discovery experience and knowledge, we have developed a robust pipeline of small molecule candidates that have the potential to bring new treatment options to patients. Our accomplishments this past year in advancing this pipeline put us in a strong position to help patients and create long-term sustainable values for our shareholders. I continue to be extremely proud and grateful to my colleagues for their collective efforts and dedication to progressing our pipeline.

Thank you Jennifer and good afternoon, everyone.

Yes.

Reflecting on our fiscal 2021 year I am proud of the exceptional advancements we've made across our entire portfolio.

By leveraging our years of drug discovery experience and knowledge, we have developed a robust pipeline of small mall.

Local candidate.

They have the potential to bring new treatment options to patients.

Our accomplishments this past year advancing the pipeline puts and puts us in a strong position to help patients and create long term sustainable value for our shareholders.

I continue to be extremely proud and grateful to my colleagues for their collective efforts and dedication to progress our pipeline.

Jay Luly: We ended our fiscal year strong with continued advancements across our clinical virology portfolio this quarter. Starting with hepatitis B, we are furthering our clinical program, with the vision of developing a combination regimen to deliver a functional cure for chronic HPV patients. EDP514, our HPV core inhibitor, has been evaluated in two phase one studies in different chronic HPV patient populations: those who have a high viral load, whom we refer to as viremic patients, and those who are on treatment with a nucleoside reverse transcriptase inhibitor, whom we refer to as a nuke-suppressed patient.

We ended our fiscal year strong with continued advancements across our clinical virology portfolio this quarter.

Starting with hepatitis B, we are furthering our clinical program.

With the vision of developing in a combination regimen.

Liberty, a functional cure for chronic HBV patients.

Jay Luly: Recently, we announced final clinical data from both of these trials in conjunction with the liver meeting hosted by AASLD, where we received a presidential poster of distinction for our virement study. Overall, final data from both studies show that the 200 milligram, 400 milligram, and 800 milligram doses were safe and well tolerated through 28 days and displayed pharmacokinetics supportive of one's daily dose. In viremic patients, treatment with EDP514 resulted in mean HPV DNA reductions of 2.9, 3.3, and 3.5 logs at 28 days for the 200, 400, and 800 milligram cohorts, respectively, compared to 0.2 log reduction, and the Placebo Group, mean HBV RNA reduction in each of these each of the three viremic treatment cohorts was at least two logs compared to a 0.02 log reduction in the placebo group.

D P. Five one for our HBV core inhibitor, that's been evaluated in two phase one studies and different chronic HBV patient populations.

Have a viral high viral load when will you referred to as the body arena.

And those who are on treatment with a nucleoside reverse transcriptase inhibitor.

Referred to.

Nuc suppressed patients.

Recently, we announced final clinical data from both of these trials in conjunction with the liver meeting hosted by E. S. L D.

We received a presidential poster of distinction for La Arena.

Overall final data from both studies show that the 200 milligram 400 milligram and 800 milligram doses were safe and well tolerated through 28 days.

Wade pharmacokinetics supportive of once daily dosing.

As Irene patients treatment with Edp 514 resulted in mean HBV DNA reductions of 2.933, and 3.5 logs that 28 days for the 200 408 hundred milligram cohorts respectively.

Compared to 0.2 log reduction.

Let's see bow group.

Mean, HBV RNA reduction in each of these each of the three treatment cohorts was at least two logs compared to 8.02 log reduction in the placebo group.

Jay Luly: Taken together, these results demonstrate that EDP-514 has clear clinical evidence of a strong safety profile alone and in combination with a NUC and displays significant antiviral activity over 28 days with a pharmacokinetic profile consistently supportive of once-daily oral doses. As recently announced, we discontinued development of EDP721, an oral HPV RNA destabilizer, based on recent emerging safety observations in the single ascending dose part of the Phase Patient safety is our top priority, and so we have decided to discontinue further development of this compound.

Taken together these results demonstrate that Edp 514 had clear clinical evidence.

<unk> safety profile alone and in combination with a nuc and display significant anti viral activity over 28 days with a pharmacokinetic profile consistently supportive of once daily oral dosing.

As recently announced we discontinued development of Edp seven to one and oral HBV RNA Destabilizer based on a recent emerging safety observations and the single ascending dose part of the phase one study.

Patient safety is our top priority and so we decided to discontinue further development of this compound.

Jay Luly: We are grateful to our principal investigator and his study team and the participants in the Phase 1 study for their commitment to HPV research, as well as to our team at Enanta for all their efforts in supporting the discovery, development, and clinical evaluation of ADP 721. We remain committed to developing a functional cure for chronic hepatitis B patients. We also believe that EDP514 will be an important component of a successful combination regimen.

We are grateful to our principal investigator study team on their participants in the phase one study.

Their commitment to HBV research as well as our team at Atlanta for all their efforts in supporting the discovery development and clinical evaluation of <unk> seven to one.

We remain committed to developing a functional cure for chronic hepatitis b patients.

We also believe that Edp 514 will be an important component of a successful combination regimen and we look forward to advance our HBV program with additional mechanisms from internal discovery efforts external opportunities for both.

Jay Luly: We look forward to advancing our HPV program with additional mechanisms from internal discovery efforts, external opportunities, or both. I would now like to turn to our respiratory virology programs, where we continue to build a leading oral antiviral treatment portfolio. Our lead RSV program includes our N-protein inhibitor EDP938, currently in multiple phase 2 studies, and our preclinical work developing a compound targeting the RSV-L protein. As a reminder, RSV is a severe respiratory infection associated with significant morbidity and mortality that has no treatments or vaccines available. The virus can cause serious disease in children, the elderly, and the immune compromised. Our lead molecule ADP-9C8 targets the replication of both RSV-A and RSV-B.

Jay Luly: It has shown robust clinical data in a phase 2a challenge study where it was safe and well tolerated and had significant effects on viral load and reduced symptoms of infection. Currently, EDP-938 is being evaluated in three clinical studies, including RSV-P, a Phase 2b study in adults with community-acquired RSV infections. RSV-TX, a Phase 2B Study in Adult Hematopoietic Cell Transplant Recipients, and RSVP, a Phase 2 Study in Pediatric RSVP While RSV, like influenza, was significantly suppressed while there were strong mitigation measures in place to control COVID-19, there's been recent increased RSV activity in various regions of the world, including parts of the United States and Europe.

I would now like to turn to our respiratory virology programs, where we continue to build a leading oral antiviral treatment portfolio.

Our lead RSV program includes our N protein inhibitor Edp 938 currently in multiple phase two studies in our preclinical work developing a compound targeting the RSV tell protein.

Jay Luly: Given this activity, we expect that enrollment in the RSVP study will be complete during the Northern Hemisphere winter season if there is no further significant increase in COVID-19 or mitigation measures in these regions. Assuming this enrollment occurs, we'll have data in the first half of 2022. For RSV-TX and RSV-P, which were initiated during the pandemic, enrollment is expected to require more than one global RO3 season, subject to the uncertainties of the continuing pandemic.

Minder RSV is a severe respiratory infection associated with significant morbidity and mortality that has no treatments or vaccines available.

Hours can cause serious disease in children, the elderly and immune compromised.

Our lead molecule Edp ninth the eight targets the replication of both RSV, a and RSV b.

It has shown robust clinical data in our phase Iia Challenge study, where it was safe and well tolerated and had significant effects on viral load on reduced symptoms of infection.

Currently Edp 938 is being evaluated in three clinical studies, including RSV P. A phase <unk> study in adults with community acquired RSV infection.

Our S E T.

He used to be study in adult hematopoietic cell transplant recipients.

RSV Peds, a phase two study in pediatric RSV patients.

Our RSV like influenza with significantly suppressed while there were strong mitigation measures in place to control COVID-19.

Theres been recent increased RSP activity in various regions of the world, including in parts of the United States and Europe.

Given this activity, we expect with enrollment in the RSVP study will be complete during the northern hemisphere winter season, but there was no further significant increase in COVID-19 or mitigation measures in these regions.

Assuming this enrollment occurs we will have data in the first half of 'twenty to 'twenty two.

That's for RSV T X and RSV peds.

Which were initiated during the pandemic enrollment is expected to require more than one global RSV season subject to the uncertainties of the continuum Colin Donald.

Jay Luly: Additionally, in RSV, our discovery initiatives are advancing as we work to develop an RSV element. L-inhibitors, another drug class that lacks viral replication, could potentially be used alone or in combination with other agents such as EDP-938 to broaden the treatment window or addressable patient problems. Our L-inhibitor program has continued to progress extremely well this year, and we're confident that we will select an optimal development candidate in this RSV metric by year end.

Additionally, in RSV, our discovery initiatives are advancing as we work to develop an RSV.

Although inhibitors or another drug class to block viral replication and could potentially be used alone or in combination with other agents such as ETP 93, eight to broaden the treatment window or addressable patient population.

Our all inhibitor program has continued to progress extremely well. This year, we're confident that we will select an optimal development candidate RSV mechanism by year end.

Jay Luly: A new L-inhibitor candidate, along with BDP-235, would achieve our stated goal of identifying two new clinical candidates among our respiratory discovery programs in 2021. We also continue to pursue our third Respiratory Discovery Program in Human Meta-Pneumovirus, or HMPV, which was first identified 20 years ago and has worldwide circulation with nearly universal infection by age five. Like with RSV, there are other vulnerable populations, including the elderly, adults with underlying pulmonary disease, and those who are immune compromised. We are nearing completion of lead optimization for potent nanomolar HMPB inhibitors and hope to select another clinical candidate in the coming months.

A new one in L. A new L inhibitor candidate along with PDP 235.

Our stated goal of identifying two new clinical candidates among our respiratory discovery programs in 2021.

We also continue to pursue our third respiratory discovery program and human Metapneumovirus or H M. P V, which was first identified 20 years ago that has worldwide circulation with nearly universal infection by age five.

Like with RSV, either other vulnerable populations, including the elderly adults with underlying pulmonary disease and those who are immune compromised.

Nearing completion of lead optimization of potent animal or H M. P V inhibitors and hope to select another clinical candidate in the coming months.

Jay Luly: Our SARS-CoV-2 program continues to progress as we develop EDP-235, our oral 3CL protease inhibitor specifically designed for the treatment of COVID-19. This quarter, we were excited to present the first preclinical data for EDP-235 at the International Society for Influenza and Other Respiratory Virus Diseases and World Health Organization Virtual Conference. These data show that EDP-235 demonstrated highly potent antiviral activity against SARS-CoV-2 with pharmacokinetic properties supporting a once-daily oral dosing regimen. In a biochemical assay, EDB235 inhibited the SARS-CoV-2 protease with an IC50 of 5.8 nanomolar and maintained this activity against proteases from SARS-CoV-2 variants.

Our Sars Covid two program continues to progress as we develop Edp 235 are all three seal protease inhibitor, specifically designed for the treatment of COVID-19.

Jay Luly: Additionally, EDP-235 potently blocked the replication of SARS-CoV-2 in multiple cellular models, including primary human airway epithelial cells, where an EC90 of 33 nanomolar was observed, positioning EDP-235 among the most potent direct-acting antivirals currently in development for SARS-CoV-2. BP-235 was also shown to have potent activity across a range of areas, as well as other Importantly, data demonstrated that EDP-235 has good oral bioavailability without ritonavir boost and favorable distribution into lung cells, as well as other key target tissues. EDP-235 is projected to have a long half-life of 16 hours and an efficacious dose of 100 to 500 milligrams once daily in humans.

This quarter, we were excited to present, the first preclinical data for Edp 235 at the International Society for influenza and other respiratory virus diseases and World Health organization virtual console.

These data show that Edp two to three five demonstrated highly potent antiviral activity against Sars Cov, two with pharmacokinetic properties supporting a once daily oral dosing rational.

In a biochemical assay ETB to three five inhibitor the Sars Covid two protease with an IC 50, or five eight in animal or maintain this activity against proteases from Sars Covid two variance.

Additionally, Edp 235, Potently block the replication of Sars Covid, two and multiple cellular models, including primary human airway epithelium cells.

We're an easy 90 of 33, even animal or was observed positioning edp 235, among the most potent direct acting anti Virals currently in development for Sars Cov two.

P. P. 235 was also shown to have potent activity across a range of areas as well as other human Corona viruses.

Importantly data demonstrated that Edp 235 is good oral bioavailability without retarding of your boosting and favorable distribution into lung cells as well as other key target tissues.

He he 235 is projected to have a long half life of 16 hours with an efficacious dose of 100 to 500 milligrams once daily and humans.

Jay Luly: In summary, the preclinical profile of EDP-235 indicates its potential to be a best-in-class, once-daily oral therapy for the treatment and prevention of COVID-19. While the pandemic may be far from over, we see COVID-19 eventually progressing from the current situation toward a more endemic disease, where effective therapeutics will continue to play a significant role. We've completed the IND-enabling preclinical studies of EDP-235 and are eager to advance the candidate into the clinic in early 2022.

In summary, the preclinical profile of Edp 235 indicates its potential to be a best in class once daily oral therapy for the treatment and prevention of COVID-19.

While the pandemic may be far from over we see COVID-19, eventually progressing from the current situation toward a more endemic disease, where effective therapeutics will continue to play a significant role.

We've completed the I N D, enabling preclinical studies of Edp, three five and are eager to advance the classic candidate into the clinic in early 2022.

Jay Luly: Lastly, this quarter we announced the decision to prioritize combination approaches for both of our NASH FXR agonists, EDP-305 and EDP-297, through an out-licensing strategy. NASH is a complex disease that we believe will likely require a combination of multiple mechanisms to provide an optimal treatment regimen.

Lastly, this quarter, we announced the decision to prioritize combination approaches for both of our Nash FX, our agonist Edp 305, and Edp 297 through an out licensing strategy now.

Actually it's a complex disease that we believe will likely require a combination of multiple mechanisms to provide an optimal treatment regimen.

Paul Mellett: Therefore, we do not plan to continue development of either program internally but instead will seek external opportunities to pursue these programs in a combined approach. Before moving to our financials, I'd like to wrap up by reiterating our upcoming milestone. We expect to select a clinical development candidate for our RSV-L inhibitor program by year-end. Looking ahead to 2022, we expect multiple milestones, including the initiation of a phase one study of our oral 3CL protease inhibitor, EDP-235, in the early part of the year.

Therefore, we do not plan to continue development of either program internally, but instead will seek external opportunities to pursue these programs in a combination approach.

Before moving to our financials I'd like to wrap up by reiterating our upcoming milestones.

We expect to select a clinical development candidate for RSV L inhibitor program by year end.

Looking ahead to 2022 we expect multiple milestones, including the initiation of the phase one study of our oral three P. L protease inhibitor Edp 235, and the earlier in the early part of the year.

Paul Mellett: We also expect, given the re-emergence of RSV in the U.S. and Europe, that enrollment in the RSVP study will be complete during the northern hemisphere winter season if there is no further significant increase in COVID-19 in those regions. Accordingly, we plan to report data from our RSVP study also in the first half of 2022. With that, I'll stop here and turn the call over to Paul to discuss their financials.

We also expect given the re emergence of RSV in the U S and Europe that enrollment in the RSVP study will be complete during the northern hemisphere winter season. If there is no further significant increase in COVID-19 in those regions.

Accordingly, we plan to report data from our RSVP study also in the first half of 2022.

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

Paul.

Paul Mellett: Thank you, Jay. I would like to remind everyone that Enanta reports on a September 30th fiscal year schedule. Today, we are reporting results for our fourth quarter of fiscal year ended September 30, 2021. For the quarter, total revenue was $23.6 million and consisted of royalty revenue earned on AVI's GlobalNet HCV product sale.

Thank you Jay.

I would like to remind everyone that in annual reports on a September 30th fiscal year schedule.

Today, we are reporting results for our fourth quarter and fiscal year ended September 30th 2021.

For the quarter total revenue was $23 6 million and consisted of royalty revenue earned on <unk> Global net HCV product sales. This compares to total revenue of $23 6 million.

Paul Mellett: This compares to total revenue of $23.6 million for the same period in 2020. However, as reported by AbbVie, treated patient volumes remain suppressed versus pre-COVID levels. AbbVie now expects total HCV sales of approximately $1.7 billion for the calendar year 2021. As a reminder, our royalties are calculated on a calendar year basis. Therefore, royalties in our fiscal first quarter ending December 31st will be calculated at the highest royalty rate for the year, and royalties for our fiscal quarter ending March 31st will be calculated at 10%, our lowest royalty rate tier for the fiscal year.

For the same period in 2020.

As reported by Abbvie treated patient volumes remain suppressed versus pre COVID-19 levels.

Abbvie now expects total HCV sales of approximately $1 $7 billion for the calendar year 2021.

As a reminder, our royalties are calculated on a calendar year basis, therefore royalties in our fiscal first quarter ending December 31st will be calculated at the highest royalty rates of the year and royalties for our fiscal quarter ending March 31 will be calculated at 10% our lowest score.

Realty rate tier in our fiscal year.

Paul Mellett: You can review our royalty tier schedule in our 2020 Form 10-K. Moving on to expenses, for the three months ended September 30, 2021, research and development expenses totaled $48.9 million, compared to $36.7 million for the same period in 2020. The increase was due to the timing and expansion of our clinical trials in our virology program. General and Administrative Expense for the quarter was $8.4 million, compared to $6.7 million for the same period in 2020.

You can review our royalty tier schedule in our 2020 Form 10-K.

Moving onto expenses for the three months ended September 32021 research and development expenses totaled $48 9 million compared to $36 7 million for the same period in 2020.

The increase was due to timing and expansion of our clinical trials and our virology programs.

General and administrative expense for the quarter was $8 4 million compared to $6 7 million for the same period in 2020.

Paul Mellett: The increase was due to increased headcount and related compensation expense in support of additional research and development activity. Enanta recorded an income tax benefit of $8.8 million for the three months ended September 30, 2021, compared to an income tax expense of $10.7 million for the same period in 2020. Enanta recorded an income tax benefit of $28.6 million compared to an income tax expense of $1.1 million for the 12 months ended September 30th, 2020.

The increase was due to increased headcount and related compensation expense and supportive of additional research and development activities.

And Andrew recorded an income tax benefit of $8 8 million for the three months ended September 32021, compared to an income tax expense of $10 7 million for the same period in 2020.

For the 12 months ended September 32021, and <unk> recorded an income tax benefit of $28 6 million compared to an income tax expense of $1 1 million for the 12 months ended September 30th 2020.

Paul Mellett: The income tax expense in 2020 was due to a tax valuation allowance charge of $18.3 million recorded against the company's deferred tax assets for the three months ended September 30, 2020. The income tax benefit in 2021 consists of net loss carrybacks against taxes paid in prior years, which would have given rise to a $38 million tax receivable on our balance sheet at September 30, 2021, the final period in which such carrybacks can be made under the 2020 CARES Act.

The income tax expense in 2020 was due to a tax valuation allowance charge of $18 3 million recorded against the company's deferred tax assets in the three months ended September 32020.

The income tax benefit in 2021, consistent net loss carry backs against taxes paid in prior years.

Just given rise to a $38 million tax receivable on our balance sheet at September 32021, the final period in which such carry backs give me me under the 2020 Cares Act.

Paul Mellett: The net loss for the three months ended September 30, 2021 was $24.6 million, or a loss of $1.22 per diluted common share, compared to a net loss of $29.3 million, or a loss of $1.46 per diluted common share, for the corresponding period in 2020. Enanta ended the quarter with approximately $352.4 million in cash and marketable securities.

Net loss for the three months ended September 32021 was $24 6 million or a loss of $1 22 per diluted common share.

Compared to a net loss of $29 3 million or a loss of $1 46 per diluted common share for the corresponding period in 2020.

And then to ended the quarter with approximately $352 4 million in cash and marketable securities.

Paul Mellett: We expect that our current cash equivalents in short-term and long-term marketable securities, as well as our ongoing royalty revenue, will continue to be sufficient to meet the anticipated cash requirements of our existing business and development programs for at least the next two years. Regarding guidance for fiscal 2022, we expect our research and development expense to be between $150 million and $170 million, and our general and administrative expense to be between $35 million and $41 million. Further financial details are available in our press release and will be available in our annual report on Form 10-K when it is filed.

We expect that our current cash cash equivalents and short term and long term marketable securities as well as our ongoing royalty revenue will continue to be sufficient to meet the anticipated cash requirements of our existing business and development programs for at least the next two years.

Regarding guidance for fiscal 2022 we expect our research and development expense to be between $150 million to $170 million and our general and administrative expense to be between 35 million to $41 million.

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

Operator: I'd now like to turn the call back to the operator and open up the lines for questions. Operator? Thank you. As a reminder, to ask a question, you'll need to press star 1 on your telephone. To withdraw your question, press the pound key.

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

Operator: Please stand by while we compile the Q&A last. Our first question comes from Brian Abrams with RBC Capital Markets. You may proceed with your question. Hi.

Thank you as a reminder to ask a question you will need to press star one on your telephone to withdraw.

Draw your question press the pound key please stand by as we compile the Q&A roster.

Our first question comes from Brian Abrams with RBC capital markets. You May proceed with your question.

Brian Abrams: Good afternoon, guys, and thanks so much for taking my question. I guess my first question's on 235. Sounds like a lot of great progress there. I was wondering if you could talk a little bit more about the IND-enabling toxicology work that you've done in preparation for this moving into the clinic and, I guess, how you're thinking about the potential therapeutic window where you would, you know, the doses that look like they could potentially be effective, I guess, where you'd be at either end of that 100 mg to 500 mg range with respect Hi, this is Jay.

Oh, Hi, good afternoon, guys and thanks, so much for taking my question I guess my first question is on two or three five it sounds like kind of a lot of great progress there.

I was wondering if you could talk a little bit more about the IND, enabling tox work that you've done in preparation for this moving into the clinic and I guess, how you're thinking about the potential therapeutic window, where you are at the doses that look like they could potentially be effective I guess, where you'd be at either end of that 100, Meg to 500 Meg range.

With respect to the.

Cushion in the therapeutic window, and then I had a follow up thanks.

Jay Luly: Brian, thanks for the question. So with 235, we've completed, you know, multi-week GOP talks and driven the drug levels to very substantial exposures, ones that we think, based on our predicted clinical dose and all the allometric scaling that we did, that we should have a very comfortable safety margin. Great. And do you have plans to explore the potential to test 2, 3, 5 in combination with any other classes?

Hi, This is Jay Brian Thanks for the question so with 235, we've completed.

Multi week GOP talks and.

Drove the drug levels to very substantial exposures once in which we think based on our.

Predicted clinical dose and all the Allometric scaling that we did that we should have a very comfortable safety margin.

Great and do you have plans to explore the potential too.

<unk> five in combination with any other classes I mean, I guess, how important do you think that that will be is there any preclinical work around that that you've done or are planning in.

Jay Luly: I mean, I guess, how important do you think that that will be? Is there any preclinical work around that that you've done or are planning, and any expectations for any sort of drug-drug interactions based on what's known so far about the metabolism?

Any.

Expectations for any sort of drug drug interactions based on what's known so far about the metabolism.

Jay Luly: Um, so that's a really good question. I guess it sort of all depends on how the pandemic twists and turns and where the ultimate variants of interest and concern might evolve over time. Right now, we feel that we've got a, um, very strong virologic profile going after all the major variants of concern today, and that at least in the model systems that we've looked at in terms of resistance to 235, it looks to have a pretty good profile overall.

So.

That's a really good question I mean, I guess it sort of all depends on how the pandemic twists and turns in and where the ultimate.

You know variance as interest and concern.

Of all overtime.

Right now we feel that we've got a.

Very strong viral logic profile going after all.

The major variance that concern today.

And that at.

At least in the model systems that we've looked at in terms of resistance to 235, it looks to have a pretty good profile overall, so given the acute nature of the clinical study.

Jay Luly: So given the acute nature of the clinical study, you know, being just a few days of treatment, we're not anticipating resistance, which is one of the reasons why you might, you know, envisage combinations. But certainly, combinations couldn't be ruled out. And there's nothing that we've seen in the profile yet today that would preclude them from any DDS, or things along those lines.

Being just a few days of treatment, we're not anticipating.

Resistance, which is one of the one of the reasons why you might.

Envision.

Combinations.

But certainly combinations couldn't be ruled out and there's nothing that we've seen in the profile yet.

Yet today.

What would preclude them from M D D.

Hum.

Or or things along those lines.

Jay Luly: People have, you know, wondered if Molnupiravir is... on the Atlantic. I think it's really going to be driven based on how the virus moves. If one drug is enough, that's what will be used. If we feel as the virology changes over time, combinations are desirable, and combinations can certainly be used. That's really helpful. One more quick one if I could squeeze it in.

People have wondered if more of a peer of yours.

It was approved.

Approved in Pfizer's protease inhibitor might be combined the answer is.

And in those instances with those drugs you know I'd have to look at all the data the <unk> wood.

I think it's really going to be driven based on how the virus moves if one drug that's enough that's what will be used.

We are feeling that.

As the virology changes over time.

Pedro.

Our desirable com.

Combinations can can certainly be built.

Jay Luly: Just curious how you're thinking now about the potential to achieve functional cure in hepatitis B with 514-based regimens, if you think that will require additional novel classes, if you're still pursuing other destabilizers, or is that class something you're not going to continue to pursue? Just curious as you kind of think about internal versus external, where you see 514 being paired up optimally to potentially achieve that. Thanks

That's really helpful. One more quick one if I could squeeze it in.

Curious, how youre thinking now about the potential to achieve a functional cure in and hepatitis B with 504 based regimens. If you think that will require additional novel classes or if youre still pursuing other destabilize the reserves that are class something youre not going to continue to pursue and just curious as.

You kind of think about internal versus external where you see 504 being paired up optimally.

We achieved that thanks.

Jay Luly: Um, another good question. So I think probably a core inhibitor plus a new agent would benefit from an additional agent or agents. I mean, that was our thesis. You know, along the way, I think Assembly looked at a core inhibitor plus a nuke and ran it out for a year or more.

So another good question.

Probably a core inhibitor plus a nuc.

Would benefit from additional an.

An additional agent or agents I mean, that's that was our thesis all along the way I think.

You know assembly and looked at a core inhibitor, plus a nuc and and ran it out for a year or more it might not have been the best core inhibitor that they use in that study, but it was still I think an interesting.

Jay Luly: It might not have been the best core inhibitor that they used in that study, but it was still, I think, an interesting study. And so even if you could do something with a nuke and a core over a longer period of time, and that certainly remains to be a possibility, I guess, I think we'd rather add another agent or agents to bring those cure numbers higher and the treatment time to the shortest possible time that you could imagine.

Study and so even if you could do something with a new kind of core over a longer period of time and that certainly remains to be a possibility I guess.

We would rather err.

Another agent or agents to bring those.

Sure.

Number is higher than the treatment time to.

The shortest possible treatment.

Jay Luly: So, you know, to that end, we're looking at things internally, and we'll widen our view in terms of looking at external opportunities for combinations as well. And then, and then out of that, I think we'll, and I'll hopefully be able to recast a combination in a good way. Thanks again.

But you could could could imagine so.

To that end.

We're looking at things internally.

Yeah, It will widen our view in terms of looking at external.

Opportunities for combinations as well and then and then out of that I think will.

And I hope to be able to to recast the combination in a good way.

Thanks again.

Youre welcome.

Operator: You're welcome. Thank you. Our next question comes from Akash Tiwari with Jeffrey. You may proceed with your question. Hey, guys, thanks so much.

Thank you. Our next question comes from our cost along with Jefferies. You May proceed with your question.

Akash Tiwari: So two on RSV and one on COVID. So in the Gilead Provastivir Phase 2 study amongst transplant patients, it was interesting; you saw a signal of efficacy, at least in one of their trials with patients with low lymphocyte counts. When you think about your transplant study, do you plan on stratifying patients based on lymphocyte counts, given that signal we've seen? Number two, how are you going to control for your RSVP study in patients who simply lie about when they actually have symptoms?

Hey, guys. Thanks, so much though to an RSP and one on Covid.

<unk> in the Gilead Prevacid your phase III study amongst transplant patients. It was interesting you saw signal.

Efficacy at least in one of their trials with patients with low lymphocyte counts. When you think about your transplant study do you plan on stratify patients based on lymphocyte counts given that signal we've seen none.

Two.

How do you how are you going to control for your RSVP study for patients who simply lie about when they actually have symptoms.

Would you be able to stratify patients based on viral load at time of dose and if so what do you expect viral load to be on average if you're dosing patients within two days of symptoms.

Akash Tiwari: Would you be able to stratify patients based on viral load at the time of dose? And if so, what would you expect viral load to be on average if you're dosing patients within two days of symptoms? And then lastly, on COVID, for EVP 235, what is the percent of drug that binds to plasma protein? And how do you think it compares versus the other protease inhibitors in development, both for Pfizer and Pardase?

Akash Tiwari: Thank you. So I may dish a couple of these over to Natalie with regard to the transplant. I'm not sure that that sort of stratification was performed in the RSV-TX. Unknown Speaker I'm not sure if it's a good study, but I'll defer to Natalie on that. We can't stratify RSVP based on liars and non-liars. What was your question with regard to that again, if you could repeat that? Unknown Speaker Yeah, I mean, it would be interesting if you could, I guess.

So I may I may dish, a couple of these over to not only with regards to the.

The transplant.

I'm not sure that that sort of stratification.

Was performed and the RSV.

RSV T X.

But I'll I'll defer to them to not only oh.

That.

We cant stratify them.

RSVP based on wires and non wires.

What what was your question with regards to that again.

Yeah, I mean, it would be it would be interesting if you could I guess.

Akash Tiwari: Look, but can you stratify patients based on the kind of viral load at the time of dose? Correct me if I'm wrong, but you should have, if it's within two days of symptoms, a viral log should be somewhere between two to three.

But can you stratify patients based on kind of viral load at time of dose right.

But correct me if I'm wrong, but you should have if it's within two days of symptoms of viral lock should be somewhere between two to three.

Akash Tiwari: And so you, you know, you could identify patients who are likely to be within two days of symptoms if you're just looking at viral load. But if, you know, a situation happens where you get a bunch of patients who actually got treatment within four days of symptoms, would the FDA allow you to stratify patients based on viral load at time of dose instead? Yeah, well, I'll defer that one to Nathalie right now, and then I'll pick up on the last one about 2C5. Hello Akash, this is Nathalie.

And so you you know you could identify patients who are likely in within two days of symptoms. If youre just looking at viral load. So if a situation happens where you got to get a bunch of patients who actually had.

<unk> got treatment within four days of symptoms.

Would the FDA allow you to stratify patients based on viral load at kind of dose instead.

Yeah, well I'll defer that one to to not.

Italy, right now and then I'll pick up on that on the last one about 225.

Nathalie: So let me maybe just touch quickly on the transplant question and then I'll try to address your question about the RSVP. Obviously, that's a good question referring to the Gideon transplant study. We did pay attention to the results, and as you mentioned, we did notice a specific response when we were looking at lower lymphocyte numbers. And that's how we designed our study. If you look at our inclusion criteria, we decided to look at subjects with less than 500 cells for the HCT recipient. And there will obviously be the possibility to look at subgroup analysis to try to understand our drug in that context too. Now as far as RSVP is concerned, that's an interesting question about lying.

And on occasion.

Let me maybe just touch quickly on the tungsten question and then I was trying to address your question about do you have a GDP. So I'll just say that's a good question. We certainly you know to the tungsten study, we did pay attention to the reserve.

You mentioned, we did not eat.

He can respond swiftly when looking at slower and emphasize number and that's how we design. Our study if you look at our English at Katanga, We decided to look at subject he's lived in.

Hi, Hunter It says Hum DHT team in Houston, and they would be obviously possibility as to look at them separately.

To try to understand Oh judge in that context.

Nathalie: I think you could argue that you could be in that same situation in any clinical study, and we don't know exactly why a patient coming in would lie about the symptoms. But as you remember, RSVP studies are a rolling subject who presents signs and symptoms within 48 hours, and obviously, there is a viral load that has been taken at multiple time points, including screening and baseline. And we will certainly be able, and that's already the plan, to look at different types of analysis, including viral load thresholds. Have I addressed the question you had about DRSVP? Yeah, that's super helpful.

No as far as I mean she'd be that's an interesting question.

I think you know.

You could argue that you can be in the turnkey tissue in any clinical studies.

Akash Tiwari: Thank you. And just on COVID on the, for 235, what is the percent of drug which is free versus that's bound to plasma protein? Thanks. I think I've lost you, Akash. I do remember the question. Unknown Speaker, Yeah, can you hear me?

We don't know exactly why a patient cause me.

But sometimes that as you remember RSVP study is enrolling subjects.

On signs and symptoms within 48 hours and how do you see the reason I don't know that that's been.

They can add to multiple time phone exceeding screening and baseline and we will be certainly a boon and that's why we did the plan to look at different type of format.

We didn't give them.

Threshold.

As I address the question you ask them do you obviously see yeah. That's super helpful. Thank you.

And just on Covid on the eye for 235, what is the percent of drug which is free versus that's bound to plasma protein.

Uh huh.

I think I am.

What kind of legs to it.

I do remember the question.

Yeah.

Amy.

Akash Tiwari: Yeah, okay, there you are. Okay. Yeah. With regard to plasma protein numbers, one of the ways that we look at this, which we think is a good way because, you know, with any plasma protein binding number, it's always an equilibrium, and then when you look at intracellular activity, many of the parameters and that equilibrium become really important on rate and off rate and so on.

Yeah. Okay. There you are okay. Yeah. So with regards with regards to I don't recall the plasma.

Protein numbers, though one of the way that we look at us, which we think is.

That's a good way because.

With any plasma protein binding numbers, it's always an equal or equilibrium.

And then when you look at intra cellular activity.

Many of them.

The parameters are.

And that equilibrium become really important on written off right and so on so what we do is we look in cellular.

Akash Tiwari: So what we do is we look in a cellular assay; we look at the antiviral activity shift when plasma protein is added, and basically, you get a serum adjustment factor that then you build into your calculations when you do the allometric scaling.

I'd say, we look at the antiviral activity shift.

When.

When plasma protein is added.

Basically you get the serum adjustment factor, but then you build into your calculations when we do the LR metrics scaling. So we did we do this scaling across multiple species, we look at the.

Jay Luly: So we do the scaling across multiple species, we look at the serum adjustment to the potency factor all of that in when we come up with our human predicted doses. So that's all embedded in that 100 to 500 milligrams taking all of that into effect. One thing that we talked about at the TIS IRV conference too: there are a number of other wild cards that you have to consider when coming up with human dose predictions.

The serum adjustment to the potency.

After all of that and when we come out with our human predicted doses and so that's all embedded in that 100 to 500 milligrams taken taken.

Taking all of that into effect one thing that we that we've talked about at the.

Yes, all your V conference to theirs.

There's a number of other wild cards that.

Is that you you have to consider.

You know when coming up with a human.

Dose predictions.

Jay Luly: And one of them that we're not taking into account but could be very favorable for us, is the fact that we see tremendously good partitioning of EDP-235 into lung alveolar macrophages. And, you know, not only might an alveolar macrophage sort of be a Trojan horse with regard to the trafficking virus But in this instance, we would also be trafficking active drugs to the lungs. So that's one of the things that we used to study back in our days of looking at community-acquired pneumonia antibiotics, looking at how drugs were taken up by and potentially transported by immune cells. And so we like that profile too.

One of them that we're not taking into account that could be very favorable for us.

Is the fact that.

We see trim.

Tremendously good partitioning.

ADP to three five and to long L dealer macrophages.

And you.

You know not only might need to know dealer macrophyte sort of be a trojan horse with regards to traffic in a virus.

But in this instance.

We would also be tracked trafficking.

Active drug to the lungs. So.

That's one of the.

Things that we used to study back in our dues of looking at community acquired pneumonia antibiotics.

Looking at how drugs, where.

Taken up by and potentially traffic by immune cells and so.

We like that profile to them.

Jay Luly: We didn't really even bake that into our dosing projection assumptions, but it does represent upside in the calculations that we've done today. Is that helpful? Yeah, that's really helpful. Thanks so much.

We didn't really even baked that into our dosing a projection assumptions, but it does represent upside.

Calculations that we've done today.

That's helpful. Yes, that's really helpful. Thanks, so much.

Youre welcome.

Akash Tiwari: You're welcome. Thank you. Our next question comes from Yasmeen Rahimi with Piper Chandler. You may proceed with your question. Hi, guys. This is Jessie on behalf of Yaz.

Thank you. Our next question comes from you know, what I mean really with.

With Piper Sandler you May proceed with your question.

Hi, Chris This is Chuck.

Oh, I'm sorry, yes.

Jessie: Congratulations on the quarter. And I had one question on the COVID-19 asset. We wanted to know if there was potential to partner this asset, what data would Enanta be looking to generate before seeking partnership? Hi, this is Jay.

From a corner and I had one question on the COVID-19 outbreak.

Who wanted to know that.

That's the potential to partner this asset what data would not have been looking to generate before seeking partnerships.

Jay Luly: Thanks for the question. I mean, you know, a partnership on a drug like this is probably inevitable at some time when you think about it. It's a global, well, it's a global pandemic right now.

Oh.

So hi, this is Jay thanks.

Thanks for the question I mean.

The partnership on a drug like this you know probably isn't inevitable at some time when you think about it it's the global.

Well, it's a global pandemic right now and it's.

Jay Luly: And it's Presumably, we'll become more epidemic and then endemic than pandemic. But no matter, it's very much a global disease infection that we're talking about here. So I think it's not a question of if, but it's a question of when. We haven't set any particular time for when that might be.

Uh huh.

Presumably will become more epidemic then.

And then the epidemic pandemic.

But no matter who it is.

It's very much a global disease infection that where we're talking about here. So I think it's not a question of if but it's a question of when we haven't set any particular win for when that might be we're just focused on.

Jay Luly: We're just focused on doing what urgently needs to be done with the drug, which is to get it into healthy volunteers as soon as possible early next year, and then to move it into phase two and three studies also early next year. And then, you know, any discussions that would come on the continuum between today and some point down the line would happen, and we would assess them as they..., you know, as they were appropriate. Okay, thank you. You're welcome.

Doing what urgently needs to be done with the drug which is together then to.

Healthy volunteers as soon as possible early next year, and then to move it into phase two and three studies also next year.

Any any discussions that would come on the continuum between today and some point down the line.

What happened then we would assess that meant they are.

You know.

Where appropriate.

Okay. Okay.

Youre welcome.

Brian Scorney: Thank you. Our next question comes from Brian Scorney with Baird. You may proceed with your question.

Thank you. Our next question comes from Brian <unk> with Baird. You May proceed with your question.

Brian Scorney: Thanks for taking the question. I was hoping to hear thoughts on the clinical development of EDP-235. It seems reasonable to think that Pfizer's protease inhibitor and Merck's nuke are going to get EUAs in the near future. How should we be thinking about the development of your PI and strategies to be able to recruit studies here?

Hey, good afternoon. Thanks for taking my question I was hoping to hear your thoughts on the clinical development of Edp 235. It seems reasonable to think that Pfizer is protease inhibitor and merck's new are going to get you a in the near future how should we be thinking about development of your pie and strategies to be able to recruit studies here do you think placebo controlled.

Brian Scorney: Do you think placebo-controlled studies will be feasible in some subgroups, or will you expect to do head-to-head studies? Is there a population you think, a subgroup that would be feasible to do placebo-controlled studies in? How many days will you be looking at in a multiple ascending dose study, and any early thoughts on where you might target in terms of number of treatment days? Is anyone else having difficulty with the audio?

Saudis will be feasible in some sub groups of where you expect to do head to head studies is there a population do you think oh subgroup that wouldn't be feasible to two placebo controlled and how many days where you'd be looking at multiple ascending dose study and any early thoughts on where you might target.

unknown: Yeah. Yeah. It seems like the speaker line or the investor line is cutting in and out. Yeah, sorry, Brian.

The number of treatment days for okay.

Does anyone else, having difficulty with the audio.

Yeah.

Airlines are the.

Industrial.

No no no.

Yeah, I'm sorry, Brian.

Brian Scorney: Brian, can you repeat the question? Sure. Can you hear me now, Tara?

I think I got the gist of your.

Sure Ken can you hear me Napa.

Operator: We can, yes, now we can. It keeps coming in and out.

Can you now.

Oh, sorry about that.

Operator: Sorry about that. No problem. So I just wanted to get your thoughts on recruiting patients for clinical studies for 2, 3, 5, and whether or not you think the availability of Pfizer and Merck's drugs would prohibit the running of a placebo-controlled study? Do you think you need to do head-to-head studies, which is sort of the fastest way?

No problem. So I just wanted to get your thoughts on recruitment of clinical studies for 235, and whether or not you think availability of Pfizer and Merck shrugs.

Would prohibit the running of a placebo controlled study do you think you need to do head to head studies, but just sort of the fastest growing and the other question was just on how many days are looking at in the multiple ascending dose study should be outside D. B, okay, and any thoughts around on how many days you would target in terms of treatment.

Brian Scorney: And the other question was just how many days you're looking at in the multiple ascending dose study. Should the FAD be okay? And any thoughts early on on how many days you would target in terms of treatment? Yeah, so the treatment days would presumably be five days; five days is what we would be aiming for. With regard to the clinical trial design, It's not clear yet that drugs with EUA Unknown Speaker, you know, emergency use authorization would need to be baked into a. None of the participants are considered FDA approved. They are not fully approved for use as a trial. Yes, can you hear me? Hi Brian,

Yeah, so the the.

The treatment days would presumably be a five five days is what we would be aiming for.

With regards to the clinical trial design.

It's not clear yet the drugs with EUA.

Emergency use authorization would need to be baked.

Baked into a.

Trial.

But they're not fully improved.

But maybe I'll, let nathalie comment on that.

Yeah.

Brian Scorney: So I think your question was about potential study design and the emerging field of new treatments and how we will position ourselves as far as designing our study and recruiting. Is that the question? Well, it was really, it was just.

Yes can you hear me.

Hi.

I think your question was about a potential study design and our emerging of new treatment.

And how we will position ourselves as far as designing a study and recruitment.

Is that the question.

Well it was really it was just one.

Nathalie: This is just on the feasibility of placebo-controlled studies versus non-inferiority studies. Well, I mean, I think, like probably many other people who are developing drugs nowadays, you know, we're having audio technical difficulties. You know, closely monitoring, you know, possibilities of study design alteration as we are getting into a phase where we will have, you know, more treatment available. I think it's going to depend on which kind of patient population you target for your registration study.

It was just on the feasibility of placebo controlled studies versus non inferiority studies, yeah, well I mean, I think as probably you know maybe meals are people developing nowadays.

Have any.

I'll keep going.

You know clearly you need when you told me you know possibilities of stadia design activation as we are getting into a phase where we have you know more treatment available and I think it's gonna depend which kind of patient population you target for your registration study and have you seen unless you go retire.

Nathalie: And obviously, you know, as you go with higher risk, it might be just unethical not to suggest, you know, having some standard of care rather than a placebo. And in that case, I think, you know, there's a higher chance, obviously, that we will have to do a non-inferiority study design. Yeah. Not only that.

It might be just unethical.

Just you know to us some standoff care huh.

National and in that case, I think you know there's the highest chance obviously, we'd have to do and not necessarily only D study design.

Nathalie: But I think, you know... Not only cut out, I think, or... Are you scaling up? I'm not sure. I'm not sure. Now it's fine. I'm not sure what's going on with the sound.

Yeah, No I haven't.

Cut out and I think her.

I mean, it's getting it I'm sure I'm not sure. It now it's fine I'm not sure what's going on with this Oh.

Nathalie: Oh yeah, no, it's you cut out when you commented that it may not be ethical. It may not be ethical.

Yeah no it.

You cut out when.

Your comments on peak.

Ethical it may not be ethical.

Nathalie: Yeah, I was, maybe I should repeat that, you know, just saying that it might not be ethical depending on the patient population you are targeting for your first study being registered. If you go, you know, after a high-risk patient, there's probably a need to add a standard of care. And obviously, that will probably lead us to have a non-inferiority study design.

Yeah, I would I was maybe I should repeat that.

Just saying that it might not be ethical depending on you know patient population you're targeting for you you know first study being registered.

The high risk patient you know, that's probably be a need to understand how a scan and have you seen that we'd probably be lead us to having known until you make the study design.

Nathalie: And I think, you know, the clinical development plan is going to be a very dynamic effort right now as we will have to adjust to new data emerging about the pandemic, the way it's going to evolve, the patient population availability, obviously, you know, speaking of vaccination versus the non-vaccinated. So I think there's a lot of questions up in the air, and we will have to adjust as best we can with our program. Great, thank you. You're welcome.

And I think you know clinical development tons going to be a very dynamic Cam you know if or twice now is we will have to adjust to new that are emerging to you know depending me the weights and evolve the patient population availability of casino speaking of vaccination.

No wonder they committed so I think there's a lot of question can be and we will have to adjust them the best with our program.

Great. Thank you.

You're welcome.

Brian Scorney: Thank you. Our next question comes from Roy Buchanan with JMP Security. You may proceed with your question. Hey, great.

Thank you. Our next question comes from Roy Buchanan with JMP Securities. You May proceed with your question.

Roy Buchanan: Thanks for taking the questions. The first one I had is on R&D guidance. It looks like you guys are guiding likely down for spending next year. But, you know, you're still ramping up RSV, you're going into the SARS-CoV-2 clinical trial, and human metanuma virus. It seems like R&D should possibly be going up. Is it just the drop off in NASH or the delay in hepatitis B? That's Rizzoli and the lower spending expenses and then.

Hey, great. Thanks for taking the question. So the first one I have is on.

R&D guidance. It looks like you guys are guiding likely down for spending next year, but you're still ramping up RSV going into the Sars Covid two clinical trial.

Meta newmar virus it seems like R&D should possibly be going up is it just the drop off in Nash or the delay in hepatitis B.

And that's resulting in the lower spending expenses and then.

Roy Buchanan: I'm going to kind of dig in a little bit on the 235 partnering question, I guess. Have you guys considered maybe monetizing Maveritt or getting a partner to bring the agent to market faster? You know, you get these stocking orders, Pfizer's $2.3 billion, Merck's got over a billion. Or is this something where, you know, more money is not going to help you get to market faster?

Although they are kind of dig in a little bit on the.

235 partnering question I guess have you guys considered.

Maybe monetize elaborate or.

Getting a partner to bring that the agent to the market faster.

Yes.

Stocking orders Pfizer's $2 3 billion.

<unk> got over 1 billion.

Or is this something where more money is not going to help you get to market faster. Thanks.

Roy Buchanan: Thanks. I heard the question. I'm not sure. I just had someone text me who's listening in and said that they're hearing both sides of the conversations very well, better than some of the participants are. Yeah, I can hear everything fine.

Maybe.

Aye.

I heard the question I'm not sure.

Just had someone text me who's listening in and said that they're hearing both sides of the conversation is very well better than some of the participants are yeah that can everything fine.

Jay Luly: Yeah, on the guidance, I think I'll let Paul chime in. I think the R&D guidance for spend is just, I think it's actually the midpoint is maybe $5 million ahead of last year. It's also, but it does factor in to the fact that we made decisions around NASH in terms of externalizing that cost that we would otherwise have been doing.

Yeah on the.

On the guidance I think I'll, let Paul chime in I think that's about right I mean R&D guidance.

Her spend is is just I think it's actually the midpoint is maybe 5 million ahead of last year.

It's also but it does you're correct it factors in to the fact that.

We made decisions around Nash.

Nash in terms of externalizing.

That cost that we would have been otherwise he's been doing theres.

Jay Luly: There's a bit of a factor from the 721 decision, but apart from that, it's allowing us to, you know, fire all the shots that we need to in our various programs, as we've outlined. So I think it's, It's fairly, fairly well studied, that that's a good number for now. With regard to Maverick, you know, as you know, Maverick is COVID impacted over the last years of the pandemic, last couple of years. Abby has seen that; Gilead has seen that in their pipeline. And so royalties, royalty revenue is down over years where it was pre-pandemic.

Theres a bit of a factor from the 721 decision.

Apart from that.

It's it's allowing us to you know.

Fire all the shots that we need to on our various programs as we've outlined so I think it's.

It's fairly.

Fairly well studied that.

Good number for now.

With regards to Maverick.

Uh huh.

No matter it is.

Has COVID-19 impacted.

Over the last.

Years of the pandemic last couple of years.

Abbvie is and that Gilead has seen that in their pipeline.

So royalties.

Royalty revenue is down over a years, where it was pre pandemic.

Jay Luly: But that said, I think we see the opportunity for that to come back. Once things normalize a bit more, PEPC patients are not spontaneously healing, and not that many of them are dying over this time period. So I think it might be prudent to watch and see how Maverick progresses as the pandemic sort of winds its way out. And certainly, at this time, I wouldn't find it necessarily the best time to try to monetize those royalties.

But that said I think.

We see the opportunity for that to come back.

Once things normalize a bit more hep C patients or not.

Spontaneous spontaneously curing and not that many of them are dying over this time period. So I.

I think it might be prudent to watch and see how maverick progresses.

And then it sort of winds its way out but certainly at this time.

I wouldnt find it necessarily the best time for them to try to monetize those royalties.

Jay Luly: And what was your last question? Yeah, I mean, I guess the question is really about spending more money on 235 to get it to market faster. You know, you see these large stocking deals for Pfizer and Merck, and those drugs have issues, as you pointed out, Merck's combination that has a black box running for DDIs, molnupiravir, is probably not the greatest drug. You know, you said it yourself, you're sitting on this extremely potent, specific drug, possibly the best in class. It seems like getting it to market as fast as possible But is, you know, if you partner with a big pharma company, is that going to get the drug to market faster? Or not, I guess. Uh, it possibly could at the right stage, right? So right now...

And what was your last what was your last question.

Yeah. It was.

I mean I guess the question is really about.

Spending more money on 235 to get it to market faster.

Large stocking deals for Pfizer and Merck and those drugs have issues as he pointed out Mark's combination has a black box warning for D. D is monotherapy is probably not the greatest dog.

You said it yourself yesterday on this extremely potent specific drug possibly best in class it seems like getting it to market as fast as possible.

What would be the best the ideal situation, but it's if you partner with the big pharma is that going to get the drugs to market faster.

Or not I guess.

It possibly could at the right stage right. So right now it's.

Roy Buchanan: It's not a resource-constrained pathway that we're in right now. So, I think, you know, again, as I mentioned, at some point down the line, opening up wider supply channels and negotiations of the types of things that you're talking about, which usually, by the way, come once you've gotten certain amounts of data, it will make sense at some point. But right now, we're not cash consumed.

It's not a resource.

Constrained.

Pathways that were.

And right now so I think you know again as I mentioned at some point down the line opening up wider supply channels.

And negotiations of the types of things that you're you're talking about which usually by the way come once you've gotten certain amounts of data.

You know we will it will make sense at some at some point, but right now we're not cash constrained.

Okay. Thanks for taking the question.

Youre welcome.

Jay Luly: Okay, thanks for taking the question. You're welcome. Thank you. The next question comes from Eric Joseph with J.P. Morgan. You may proceed with your question. Great, thanks for taking the time to answer my question. Just a couple on HPV from us. First, I'm wondering if you could give a little more, a little bit more context around the nature of the adverse safety net and Y-Vitamin S. Piney, David Foxworth. I'm also curious to know whether there's perhaps a path forward against the target or even with 71 as an alternative route of administration, could it be administered perhaps simultaneously safely?

Thank you. Our next question comes from Eric Joseph with Jpmorgan. You May proceed with your question.

Alright, great. Thanks for taking the questions just a couple on HBV from us.

First I'm wondering if you could put a little more a little bit more context around the nature of the adverse safety events.

With that one.

Why.

I E.

Fox Sports.

And I'm also curious to know whether.

Whether there is perhaps.

Four to get to the target or even with Covid one of the.

With an alternative route of administration could it be.

Could it be administered.

Perhaps I could safely safely.

Eric Joseph: And then maybe finally, just curious to kind of get some of your additional thoughts on what other HPV targets are of interest as part of a company's strategy with 5.4 that might also be... amenable to oral registration. Thanks. Yeah, so thanks for the question, Eric.

And then maybe finally, just curious to kind of get some of your additional thoughts on what other H.

H B b targets are of interest as part of it.

With.

That might also.

Our medical to oral administration.

Jay Luly: So the study is, Dosing has been completed, but the study is still ongoing. So it's still, we're still actively monitoring the study. We're not commenting on safety results observed. What does it mean for 7-2-1? I don't think 7-2-1 is going to go forward.

Yeah. So thanks for the question Eric.

Questions I guess.

So the study is.

Dosing has been completed but the study is still ongoing so it's still.

We're still actively monitoring the study.

We're not commenting on our safety results observed.

Jay Luly: I don't think it's a Radov administration question. You know, is it a mechanism? You know, I guess right now.

What does it mean for 721 I don't think 721 is gonna go forward I don't think that's a route of administration.

Question.

Is it the mechanism.

I guess right now.

As far as defining next steps at this point, we're sort of reviewing all the data in order to fully understand these results, but before deciding on next steps whether it's with another.

Jay Luly: Unknown Speaker, As far as defining next steps, at this point, we're sort of reviewing all the data in order to fully understand these results before deciding on next steps, whether it's with another destabilizer someday or if it's with other mechanisms that we would pursue. I think independently, you know, I'm, We're going to focus on other mechanisms that could possibly be added to this, because you may never understand, you know, what the destabilizer situation was. So I'm not going to bank on that fact.

Stabilizer, some day or if it's with other mechanisms that we would pursue I think independently.

Okay.

We're going to focus on other mechanisms that could possibly be added to this because you may never understand.

You know what the Destabilizer situation was so I'm.

I'm not going to bank on on that track of course, we will try to understand it as fully as we can but.

Jay Luly: Of course, we'll try to understand it as fully as we can. I think for, you know, when we had a core inhibitor plus a nuke out there, effectively a double, we were already looking for a third mechanism, not knowing whether or not we would ever need it. That was the destabilizer.

I think for.

We were already when we had.

Our core inhibitor plus a nuc out there effectively double we were already I'm looking for a third mechanism not knowing whether or not we would ever need it and that was the destabilizer and even once we got that one we were still thinking about other mechanisms beyond.

Jay Luly: And even once we got that one, we were still thinking about other mechanisms beyond, you know, a triple. Again, not knowing whether we would ever need them, but to be constantly looking, you know, inventing new drugs in-house and also looking for external mechanisms that we might either be able to bring in or license. Because, again, it's going to be a combination therapy with more than a couple agents on it. I think that's certainly going to be the case. I mean, there are other mechanisms out there that are oral. You can look at some of the immunomodulatory mechanisms that are out there.

A triple again, not knowing whether we would ever need them, but two to be constantly looking.

Inventing new drugs are in house and also looking for external mechanisms that.

So we might either be able to bring in or our license because again, it's going to be.

It's going to be a combination therapy with with more than a couple agents on it I think that's a.

Certainly going to be the case I mean, there are other mechanisms out there that are oral you can look at.

Some of the modular Tory mechanisms that are out there and that's certainly.

Jay Luly: I mean, that's certainly an approach that we have been looking at and thinking about and considering, and there are still other ones. So anyway, you know, we'll be reviewing that over the course of time and revamping that HPV strategy with new combinations. And once we've got that sorted internally, we'll start to talk about it publicly. Thank you. Our next question comes from Zegbe Jalal with Brock Capital Partners. You may proceed with your question.

And approach that we had been looking at and thinking about and considered.

And there are still other ones.

So anyway.

We will be reviewing that over the course of time and revamping.

That HBV strategy with new combinations.

Once we've got that sorted internally we'll start.

To talk about it publicly.

Thank you. Our next question comes from mid July with Roth Capital Partners. You May proceed with your question.

Okay.

Jay Luly: Hi, thanks for taking my questions. I just wanted to quickly follow up on Eric's question about the HPV program, just notably his question about why some of the safety signals may have been missed preclinically. Is this something that couldn't have been determined preclinically? I know you don't want to say what the exact AEs were, but I was just curious about that.

Hi, Thanks for taking my questions I just wanted to quickly follow up on <unk> question about the HBV program, just notably his.

His question about.

Right some of the safety signals me happiness, Brooklyn, and Queens is something that could have been determined quite quickly I know you don't want to say what the exact math I was just curious about that.

Zegbe Jalal: No, it's again, it's really kind of hard to explain. I mean, we, there were other members of this mechanism that had been studied in the past. I mean, Roche had a molecule, they took it into phase one and then disappeared from phase one, but there hasn't really been any public comment with regard to what happened there. Our Buddhists had some molecules or a molecule, I guess that they had worked on, and they were in shorter-term safety studies, and apparently, I think it looked okay, and then when they got their longer-term safety studies in.

No it's again.

It really kind of hard to explain I mean, we.

I mean, there were other members of the.

Mechanism that had been studied in the past I mean Roche had a molecule. They took it into phase one and then disappeared from phase one, but hasn't really been any public comment.

With regards to.

You know what what happened there.

Or Buddhist had.

The molecules are a molecule I guess that they had worked on.

And they were.

Shorter term safety studies.

Apparently I think I looked okay, and then when they got their longer term safety studies.

Jay Luly: They ended up finding a safety signal and then repeating the study and then seeing another signal and then terminating the molecule. So for us to even move to that next step, the bar in our minds was to make it at least past the 13-week safety signal that others had seen, at least pre-clinically. So we spent a lot of time engineering 721.

They ended up finding a safety signal and then and then repeating the study and then seeing another signal and then and then terminating the molecule. So.

For us to even move to that next step the bar in our minds was making it at least past the 13 week.

Safety.

Signals that others haven't seen at least pre clinically and so.

You spent a lot of time engineering.

721, we took it through them.

Jay Luly: We took it through safety studies and in multiple species, and it had a very clean profile with regard to safety, any safety observations. And so it was just an unusual, unexpected finding in a phase one study. I mean, sometimes this happens; it's rare.

If these studies and.

In multiple species.

<unk> had a very clean profile with regards to safety.

Tradition, and so it.

It was just the unknown.

No unusual unexpected findings.

Phase one study.

This happens it's rare.

Jay Luly: It's even more rare for Enanta on average, but in this case, it did, about about the sum of it. Thanks Jay, that was really helpful. And then a follow-up to that, at one point you noted that we would be interested in the S-antigens, so I was just wondering if you were to go and add another candidate, would it be something again against the S-antigens? Well, certainly, if we found a desirable target to take that on, that's not a bad idea.

Even more rare for naphtha on average, but in this case it did so.

That's about.

That's about the sum of it.

Thank you that was it.

Really helpful. And then a follow up to that Oh, one thing I didnt really be interested in the S. Antigen. So I was just wondering if you were to go and add another candidate would it be something again against the S antigen.

Well certainly if we found the desirable target too.

Jay Luly: F-antigen is one of the things that we obviously need to deal with in some form, either by shutting down the source of its being produced or dealing with it directly or otherwise compensating with an immune approach that can help overcome it.

To take that on that would be that's not.

Not a not a bad idea.

S antigen is one of the things that obviously.

To deal with in some form either by.

You know shutting down the source of it's being produced.

We're dealing with it directly.

Or otherwise.

Compensating with an immune.

Approach that a 10 10.

And.

Zegbe Jalal: So, any, you know, as handage and modifiers would be something to the extent that we could find them an appropriate methodism to target would be on our list. I just have two more. The first is just thinking about the timeline for the HPV program. So, you know, I know you have a couple of things in the works in terms of candidates. I was just wondering how far are those who enter the clinic?

Help overcome that so yeah.

It's okay.

Pendants, and modifiers would be something to the extent that we could find it an appropriate mechanism to target.

It would be on our on our list.

Zegbe Jalal: And then, is there anything that you can do to kind of optimize the timeline, meaning move forward with the combo as much as you can before adding in the third agent that may be a little bit behind?

Things can I just have two more the first is just thinking about the timeline for the HBV program. So you know I know you have a couple of things in the works in terms of candidates I was just wondering how far are they listen entering the clinic and then is there anything that you can do to kind of optimize the timeline, meaning they were filed with that.

I'll come by as much as you can before adding in <unk> that may be a little bit behind.

Jay Luly: Yeah, I think our priority is going to be focusing on third agents right now, and, Like I said, we'll be focusing on the internal pipeline as well as external opportunities to do that. Thank you. So you're not going to be limited by, you know, your internal candidates because you could pull something from another company or something like that.

No I think our priority is gonna be focusing on third agents.

Right now and.

Like I said, we'll be we'll be focusing on the internal pipeline.

As well as external opportunities to do that.

Zegbe Jalal: So that's good to know. And then the last one here is just a high-level question, you know, for folks that are a little bit apprehensive now, you know, having two programs kind of change a little bit, meaning the NASH and now the HPV program. I like how you said that, you know, this is very rare, at least for the HPV. It's really rare to have something like this happen.

Thank you, you're saying you're not gonna have been limited by your own internal candidates because you're capable of something.

From another company or something like that so that's good to know and then the last one here is just a high level question, you announced for something a little bit apprehensive now.

And you know two programs kind of you know change a little bit at meaning that the Nash and now the HBV program I like how you set that you know that is there were at least for the HBV antibody rare to have something like this happen to enhance that and so I think it'd just be nice to kind of you got thoughts on you know.

Jay Luly: And so I think it would just be nice to kind of hear your thoughts on, you know, the robustness of your proclinical work that you typically do across your pipeline. And I guess for folks that may be losing a little bit of confidence, you know, how do you kind of keep people confident in what it is that you guys are doing at Enanta? Hey, you know, this is nothing unusual in the industry or in biotech or pharma. It happens every, every day. It just, I think what's surprising is it rarely happens at Enanta. But it's, but it is part of the business.

The robust net of your preclinical work that you typically do not talk about pipeline and I guess my folks that maybe losing a little bit of confidence you know how do you kind of keep you know so I'm confident in what it is that you guys are doing at Indiana.

Hey.

This is nothing unusual in the industry or.

Biotech or pharma Sevens every every day it just I think what's surprising is rarely happens sitting there until that.

But it is part of the business I mean, youll find a preclinical finding sometimes that never manifest themselves in human test results ever.

And occasionally you'll find the converse.

Jay Luly: I mean, you'll find preclinical findings sometimes that never manifest themselves in human test results ever. And occasionally, you'll find the converse. So, you know, we pushed six programs together with no safety findings at Alper, our way of doing business, including several that are in the clinic now and have been used in lots and lots of patients. So, again, this is a very unusual sort of one-off finding, and people should think about it in that way. I mean, that's the nature of the business.

So.

We pushed six programs together with no safety findings.

At altar.

Our way of.

Doing business, including several that are in the clinic now it had been in lots and lots of patients. So.

Again this is a.

Very unusual sort of one off.

Finding and.

People should think about it in that way and that's the nature of the business we've got.

Jay Luly: We've got a very strong preclinical, you know, compound characterization group at Enanta, looking at DNPK, safety formulation, on and on and on. And I think, overall, our track record speaks for itself. Thanks, Jane. Congratulations on the program. You're welcome. Thank you. Our next question comes from Roanna Ruiz on the SVB letter. You may proceed with your question. Great, thanks for fitting me in. One question for HBV: I was curious about 514, which dose are you most likely to advance forward into combination trials considering that we've seen some similar HBV DNA reductions between the 400 milligram and the 800 milligram doses so far?

A very strong.

Preclinical.

Compound characterization.

Group at Atlanta, you know looking at the M. P K safety.

Formulation on and on and on and I think.

Overall, our track record speaks for itself.

Thanks, and congrats on the progress.

You're welcome.

Thank you. Our next question comes from Randle Reece with SBB Leerink you May proceed with your question.

Great. Thanks for fitting me in one question for H E. B I was curious for 514, which dose or you're most likely to advance forward into combination trials considering that we've seen some similar HBV DNA reductions between the 400 milligram and the 800 milligram dose.

So far.

Roanna Ruiz: Yeah, you know, they're all, All the doses look good, actually. So we'll make the final decision, you know, when we pair up and do the ultimate study. But when you look at, you know, 200, 400, 800, they all had, you know, very nice long drops in DNA and RNA, if you look at the Viremic study. I think a lot of that had to do with the fact that even at the lowest of the three doses, we were already driving around 10 times the speed of the adjusted DC 90. And, you know, 400? We were 20 fold above that.

Yeah.

Sure.

All the doses right.

Actually so we'll make the final decision you don't want more pairing up and when the ultimate study, but when you look at it.

204 hundred 800.

They all had very nice log drops and DNA and RNA, if you'll give us irenics study.

I think a lot of that had to do with the fact.

At even at the low.

The lowest of the three doses, we were already driving around 10 times.

You know the adjusted you see 90.

As you know 400, we were at 20 fold.

Above that.

So we we drove very high drug exposures are very safely.

Jay Luly: And so we, we drove very high drug exposures, very safely over the course of a full month and HPV patients. So, you know, I, any of them could probably be fine doses to go forward with, I think, in a general sense, you try to look at you know, the highest, or a, you know, a very robust dose just to, you know, to make sure in a broad section of patient population that you're exerting a lot of pressure on the virus.

Over the course of a.

A full month in HBV patients so.

You know I think any of them could probably be find doses to go forward with I think.

In a general sense do you try to look at.

The highest.

Or a you know a very robust dose just to you know to.

To make sure in a broad section of patient population that you're you're exerting a lot of.

Jay Luly: But, you know, so far, we've done that even with the lowest dose. So, if we get closer to a specific combination, we can talk about a specific trial design, but I think all those look good and make sense. Thanks. You're welcome. Thank you. Our next question comes from Liisa Bayko with Evercore.

Pressure on the virus, but.

So far we are.

We've done that even with the lowest stuff so we get closer to a specific combination.

We can.

Talk about a specific trial design, but I think they all doses look good.

Understood makes sense. Thanks.

Youre welcome.

Thank you. Our next question comes from Lisa Baker with Evercore. You May proceed with your question.

Roanna Ruiz: You may proceed with your question. Hi, thanks for taking the question. Okay, just first on, This is 514 in the liver meeting data. You seem to have an inverse dose response on RNA, but I know DNA was pretty tight actually across all the doses.

Hi, Thanks for taking my question just first on them.

Before 514 and that liver meeting data.

And you seem to have an inverse dose response on.

Liisa Bayko: Is that just some function of small numbers, or what's the right way to think about that trend there? Yeah, it was a very, you know, it was a very good time. Paul Mellett, Jay Luly, Wing Yip, Antonio Arce, Douglas Buchanan, Roanna Ruiz, Luke Herrmann, Hi Liisa. Thank you for your question. It's true that when you look at the numerical value of the three doses in the viremic patient, in particular, it looks like it may be a reverse dose dependency.

RNA.

D&A was pretty tight actually across all of those things that just.

Function of small numbers of what what's the right way to think about that.

From there.

Yeah. It was a very.

It was a very.

Small dose response, even on the Ah <unk>.

Because I think we were nailing it even at the lower dose and there's probably a little bit of a little bit of a wobble thereafter, but.

I will I'll, let Natalie come on comment on that further.

Hi, Lisa you. Thank you for your question I mean, it's it's truly that when you look at the total.

Value of a discrete decision does that any patient in particular, it looks like it might be a reverse dose dependent I think it's important to note that I'm you know it's a small sample size. We are believing in the you know in the HBV RNA not only at baseline, but also swelled to.

Liisa Bayko: I think it's important to note that it's a small sample size with variability in the HPV RNA, not only at baseline but also throughout the treatment duration and the distribution of the patients in those small studies where you have six patients per arm who receive the active drug. Depending on when they come into the study with a higher baseline HPV RNA compared to a lower HPV RNA, that can change a little bit your mean value at the end per cohort. We look very closely at each individual patient for each cohort, and there's a little bit of difference in the distribution with the 800 milligram dose, where we had more subjects.

Treatment duration and did you see a vision of the patient in the small study easily you have you know six patients per arm received active drug depending on when they come into the study we use a higher baseline HPV M&A compare to NOLA HBV RNA, you know that can change in either.

You mean <unk>.

So cohort, we look very closely to each individual patient for each cohort and there's a little bit of.

Our differentiated distribution, reaching 800.

Meaning run well, we add more subjects, we Uh huh.

Nathalie: We had a higher HPV RNA at baseline compared to the two other arms. So if you try to normalize and remove those subjects who were maybe, I'm going to say, outliers compared to the other arm, you know, it comes pretty much even. It is just an artifact that shows the distribution and variability of the HPV RNA.

That's why wouldn't it be V O N E a baseline compare to detours that.

You should try to normalize and removes the subjects who were maybe.

I'm gonna see outlier compared to deal with it you know.

It comes pretty much even if it is just that not decided to chico's distribution and viability of the HPV yummy.

Liisa Bayko: Okay, great. Thank you. And then, just on timing for RSV, I was looking at the trends in the United States, and it actually looks like it's coming down, at least right now, per the CDC. Are you planning to kind of follow patients globally, Jay, and that's how you complete, like, I'm assuming that it's coming down here, but it's probably rising in other parts of the world.

Okay, great. Thank you.

And then just on timing for RSV.

And I was looking at the trends within the United States that actually looks like its coming down at least right now I'm pretty sure he's planning.

Just kind of follow up patients like globally today, and that's how you complete I am assuming thats coming down here is probably rising either parts or somewhere else that right way to think about it.

Jay Luly: That's the right way to think about it. And then, you know, if you're going to get RSVP, you know, data, you know, in 2022 PEDS and RSVT-X, if we have an increase in cases, could we maybe count on some data from those as well next year? Yeah, I would say it's unlikely for RSVP, the pediatric study and transplant. I think we'll need more than one global season. And there are at least more than one; we're heading into one now.

And then you know it.

If you're gonna get RSVP no data yet.

And plenty plenty to peds and RSV T Act.

We have an increase in cases can we need to count on some data from those as well.

Sure thing.

Yeah I would.

I'd say its.

Likely for RSV peds, the pediatric study and transplant I think we will need.

More than one global season, and or at least more than one we're heading into one now.

Jay Luly: And this will be the first real season that either of those studies have experienced, assuming that it is a real season this time. And, you know, I look at the numbers that you're looking at where, you know, it spiked a little bit when people started relaxing some of the masks, and then it seemed to be coming down a little bit. But recall that, at least now, we're just heading into the beginning of what would normally be a full season that typically peaks in January and February of a given year, at least in the Northern Hemisphere.

And this will be the first.

This will be the first real season that either of those studies has experienced assuming that it is a real steep in this time.

You know I I.

I look at the numbers that.

Ah you're looking at where you know it.

It spiked a little bit when people started relaxing some of the mass none of it.

And it.

Seem to be coming down a little bit, but recall that were at least heading just now we're just heading into the beginning of what would normally be.

The fall season.

Typically peaks in January and February, but given your at least in our.

Jay Luly: So we have trial sites all over the world, US, EU, Southern Hemisphere, Pan-Asia. And so to the extent that we get into what will hopefully be a fairly normal season, then we're pretty confident we should be able to wrap things up and report out in the first. Okay, great. Can you tell us how many patients you've enrolled thus far from the total anticipated? Now, we typically don't give sort of interim post updates because it's a splotchy thing.

In the northern Hemisphere.

So we have trial sites all over the world.

You are you southern hemisphere.

Pan Asia.

And so to the extent that we get into what will hopefully be a fairly.

Normal season.

Then.

We're pretty confident we should be able to to wrap things up and report out in the first half.

Okay, Great can you tell us how many patients.

Enrolled thus far is off to a total anticipated.

No.

We typically don't give sort of the interim stuff data because it is a splotchy thing you know you won't you'll go through dry spells men get hot zones.

Jay Luly: You know, you'll go through dry spells and get hot zones and stuff. So it's really, What you need to do is just look at it as a whole, and, and, you know, rely on our guidance based on assumptions and the, and the, and the background of the virus. But I think we're, you know, we did see an uptick very much so a little while ago when the cases were starting to rise.

So it's it's a it's really.

You know what you need to do is just look at it.

As a whole.

And.

Rely on.

Our our guidance based on assumptions and.

And the backdrop of the.

The virus.

Okay.

I think we're.

We did see an uptick very much so you know a little while ago.

When the cases were starting to rise so I think that's right.

Jay Luly: So I think that's very encouraging. We were able to capitalize on that. And so again, to the extent that we have a fairly normal-looking season, I think it should be quite doable.

That's again very encouraging and we were able to capitalize on that.

And so again to the extent that we have a fairly normal working season, I think it should be quite doable.

Liisa Bayko: Great, thank you very much. You're welcome. Thank you, and I'm not showing any further questions at this time. I would now like to turn the call back over to Jennifer Viera for any further remarks. Thank you to everyone for joining us today. If you have any additional questions, please feel free to contact me by email or call my office.

Great. Thank you very much.

Youre welcome.

Thank you and I'm not showing any further questions. At this time I would now like to turn the call back over to Jennifer Viera for any further remarks.

Thank you to everyone for joining us today, if you have any additional questions. Please feel free to contact me by email or call. My office. Thank you. So much have a good night bye bye.

Jennifer Viera: Thank you so much. Have a good night. Bye-bye. Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.

Thank you. This concludes today's conference call. Thank you for participating you may now disconnect.

Okay.

Operator: [music] Music Unknown Executive, Jay Olson, Unknown Executive, Jay Olson, Unknown Executive, Jay Olson, Unknown Executive, Jay Olson, Unknown Executive, Jay Olson, Unknown Executive, Jay Olson, Unknown Executive, Jay Olson, Unknown Executive, Jay Olson, Unknown Executive, Jay Olson, Unknown Executive, Jay Olson, Unknown Executive, Jay Olson, Unknown Executive, Jay Olson, Unknown Executive, Jay Olson, Unknown Executive, Jay Olson, Unknown Executive, Jay Olson, Unknown Executive, Jay Olson, Unknown Executive, Jay Olson, Unknown Executive, Jay Olson, Unknown Executive, Jay Olson, Unknown Executive, Jay Olson, Unknown Executive, Jay Olson, Unknown, Unknown Executive, Jay Olson, Jennifer Viera, Scott Rottinghaus, Enanta Pharmaceuticals Inc, Unknown Executive, Jay Olson, Jennifer Viera, Scott Rottinghaus, Enanta Pharmaceuticals Inc, Unknown Executive, Jay Olson, Jennifer Viera, Scott Rottinghaus, Enanta Pharmaceuticals Inc, Unknown Executive, Jay Olson, Jennifer Viera, Scott Rottinghaus, Enanta Pharmaceuticals Inc,..

[music].

Operator: . Liisa Bayko, Paul Mellett, Jay Luly, Wing Yip, Antonio Arce, Douglas Buchanan, Roanna Ruiz, Luke Herrmann, Tara Kieffer, Unknown Executive, Jay Olson, Jennifer Viera, Scott Rottinghaus, Enanta Pharmaceuticals Inc Liisa Bayko, Paul Mellett, Jay Luly, Wing Yip, Antonio Arce, Douglas Buchanan, Roanna Ruiz, Luke Herrmann, Tara Kieffer, Unknown Executive, Jay Olson, Jennifer Viera, Scott Rottinghaus, Enanta Pharmaceuticals Inc Liisa Bayko, Paul Mellett, Jay Luly, Wing Yip, Antonio Arce, Douglas Buchanan, Roanna Ruiz, Luke Herrmann, Tara Kieffer, Unknown Executive, Jay Olson, Jennifer Viera, Scott Rottinghaus, Enanta Pharmaceuticals Inc, [music].

.. .. .. .. .. .. .. , , , , , , , , , , , , , , , , ,

Yeah.

Okay.

[music].

Yes.

Uh huh.

Okay.

Yes.

[music].

[music].

[music].