Q3 2021 Enanta Pharmaceuticals Inc Earnings Call

Good afternoon, and welcome to the announcer Pharmaceuticals fiscal third quarter 2021 financial results conference call.

Operator: Good afternoon, and welcome to Enanta Pharmaceuticals' fiscal third quarter 2021 Financial Results Conference Call. At this time, all participants

At this time, all participants are in listen only mode.

Operator: are in listen-only mode.

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

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 third quarter financial results was issued this afternoon and is available on our website.

Jennifer Viera: Thank you, operator, and thanks to everyone for joining us this afternoon. The news release with our fiscal third quarter financial results was issued this afternoon and is available on our website. On the call today is Dr. J. Lulai, President and Chief Executive Officer, Paul Mellet, our Chief Financial Officer, and other members of the Nantas 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.

On the call today is Dr. Jay and New life, President and Chief Executive Officer, Paul Mellett, Our Chief Financial Officer, and other members of the Nance and senior management team.

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

Actual developments and results to differ materially from those statements. A description of these risks is and our most recent form 10-Q and other periodic reports filed with the SEC and and so does not undertake any obligation to update any forward looking statements made during this call.

Jennifer Viera: A description of these risks is in our most recent Form 10Q and other periodic reports filed with the SEC. Ananta does not undertake any obligation to update any forward-looking statements made during this call. With that, I'd now like to turn the call over to Dr. J. Luli.

With that I'd now like to turn the call over to Dr. Jamie why Jay.

Jay R. Luly: Thank you, Jennifer, and good afternoon, everyone. Our fiscal third quarter was marked by the achievement of several important milestones and continued progress across our clinical portfolio. Starting with COVID-19, we are pleased to announce that we have identified a clinical development candidate, EDB-2-3-5, an oral protease inhibitor specifically designed to treat SARS-CoV-2 infection and potentially other coronavirus infections. We are eager to progress this program into the clinic and are on track to initiate a phase one study of EDB 235 early next year.

Thank you Jennifer and good afternoon, everyone.

Our fiscal third quarter was marked by the achievement of several important milestones and continued progress across our clinical portfolio.

Starting with COVID-19, we were pleased to announce that we have identified a clinical development candidate Edp 235, and oral protease inhibitor, specifically designed to treat Sars COVID-19, 2 infections and potentially other corona virus infections.

We are eager to progress this program and at the clinic and are on track to initiate a phase 1 study of Edp 235.

Early next year.

Jay R. Luly: In Hepitis B, we're excited by the progress we've made with EDP 514 and EDP 721, which we are developing as part of an all-oral combination regimen to achieve a functional cure. We expect to begin dosing in our phase one study of EDP 721, a novel oral HB RNA stabilizer, this month. Additionally, this quarter, we announced positive phase 1B 28-day data for our core inhibitor, EDP 514, and two important patient populations.

And hepatitis B, we are excited by the progress we've made with Edp 514, and ETP 721, which we're developing and as part of an all oral combination regimen and to achieve a functional cure.

We expect to begin dosing and our phase 1 study of Edp 7 to 1 and novel oral HBV RNA Destabilizer the smart.

Additionally, this quarter, we announced positive phase 1 B 28 day data or a core inhibitor Edp 514, and 2 important patient populations chronic HBV patients who have high viral load when we referred to and it's of Irenic patience and chronic HBV patients who are on treatment with a nuclear.

Jay R. Luly: Chronic HBV patients who have a high viral load, whom we refer to as viremic patients, and chronic HPV patients who are on treatment with a nucleoside reverse transcriptase inhibitor, whom we refer to as nuke-suppressed patients.

Syed and reverse transcriptase inhibitor, and we referred to as nuc suppressed patients and significant progress we've made across our HBV program and brings us closer to our goal of developing and all oral and functional cure for patients.

Jay R. Luly: The significant progress we've made across our HBB program brings us closer to our goal of developing an all-oral functional cure for patients. Moving to the rest of our pipeline, we have three ongoing phase two clinical studies investigating 938 for respiratory syncytial virus or RSV, and two ongoing clinical studies for candidates to treat non-alcoholic steato hepatitis or NAC. In addition to our clinical programs, we continue to progress our respiratory virus discovery initiatives to identify an L-inhibitor for RSV and an inhibitor for human metanumovirus or HMPV. With that, I'd like to dive deeper into each of the programs that make up our robust pipeline, beginning with SARS-Cove 2.

Moving to the rest of our pipeline, we have 3 ongoing phase III clinical studies investigating 93, 8 for respiratory syncytial virus or RSV and 2 ongoing clinical studies for candidates to treat non alcoholic Seattle and hepatitis or Nash.

In addition to our clinical programs, we continue to progress our respiratory virus discovery initiatives and identify and L inhibitor for RSV and and inhibitor for human Metapneumovirus or H N P V.

And I'd like to dive deeper into each of the programs that make up our robust pipeline beginning with Sars Covid 2.

We were pleased to have selected Edp 235, a direct acting antiviral oral protease inhibitor.

Jay R. Luly: We're pleased to have selected EDP-235, a direct acting antiviral oral protease inhibitor, as our clinical development candidate for SARS-Cope 2 and plan to initiate a clinical study early next year. As SARS-CoV-2 continues to mutate and new variants arise, we believe there remains a need for a potent oral treatment that is specifically designed to inhibit replication of this virus and are excited to progress this program. Well, vaccines and antibody therapeutics and development today target the viral spike approach.

Clinical development candidate for Sars, Covid, 2 and plan to initiate a clinical study early next year.

As far as co 2 continues to mutate and new variance of rise. We believe there remains a need for a potent oral treatment that is specifically designed to inhibit replication of this virus and are excited to progress this program.

Well vaccines and antibodies therapeutics and development today targets the viral spike protein ETP.

Jay R. Luly: EDP 235 has been specifically designed to target a conserved region and the active site of an enzyme essential for SARS-Cope 2 replication, so we do not expect mutations in the spike protein to significantly affect the activity of our candidates.

E. D. P 235 has been specifically designed to target and are conserved region and the active site of an enzyme and central for Sars Covid 2 reputation. So we do not expect mutations and the spike protein to significantly affect the activity of our candidate.

Jay R. Luly: Further, EDP2-P-3-5 potently and selectively inhibits SARS-Cove 2 replication in multiple cellular models, including primary human airway epithelial cells, where it demonstrated an EC90 of 33-9 molar. Importantly, activity is retained against currently circulating SARS-Cove 2 variants, and a high barrier to resistance has been observed. Additionally, EDP 235 demonstrates preclinical properties supportive of a once daily oral dose. If we are successful, our vision is for an early diagnosis of COVID-19, followed by outpatient treatment with a highly potent and targeted oral therapy.

Further edp 235, potent potently and selectively inhibit Sars COVID-19, 2 replication and multiple cellular models, including primary human airway epithelium cells, where it demonstrated and <unk> 90 of thirty-three and anymore.

And importantly activity has retained against currently circulating Sars Covid 2 variants and a high barrier to resistance has been observed.

Additionally, Edp 235 demonstrates preclinical properties supportive of once daily oral dosing.

If we were successful on revision as far and early diagnosis of COVID-19, followed by outpatient treatment with a highly potent and targeted oral therapy.

Shifting gears to HBV, we recently announced preliminary data from the first 2 dose cohorts of our phase 1 B study of Edp, 5.1 and 4 and viremia and chronic HBV patients, which further demonstrated the compound safety and tolerability as well and its ability to reduce HBV DNA levels significantly.

Jay R. Luly: Shifting gears to HBV, we recently announced preliminary data from the first two dose cohorts of our Phase 1B study of EDP-514 in Enviremic Chronic HBV patients, which further demonstrated the compound's safety and tolerability, as well as its ability to reduce HBV DNA levels significantly over the 28-day dosing period. To briefly recap the data, 16 patients were randomized to receive daily doses of either 200 milligrams or 400 milligrams of BDP 514 or placebo for 28 days.

Over the 28 day dosing period to.

To briefly recap the data 16 patients were randomized to receive daily doses of either 200 milligrams or 400 milligrams of Edp 514, or placebo for 28 days mean reductions and HBV DNA of 2.93, 0.3, and zero point too low.

Jay R. Luly: Mean reductions in HBV DNA of 2.9, 3.3, and 0.2 logs were observed in the 200 milligram, 400 milligram, and placebo groups, respectively, with a maximum reduction of 4.2 logs in the 400 milligram group versus 0.5 log in the placebo group. Additionally, more patients receiving EDP 514 had HPV DNA below the lower level of quantitation compared to none who received placebo. Additionally, mean reductions in HBV RNA of 2.9, 2.4, and 0.3 logs were observed in the 200 milligram, 400 milligram, and placebo groups, respectively, with a maximum reduction of 4.8 logs with EDP 514 versus 1.9 logs with placebo. HBV RNA was undetectable at day 28 in eight patients in the 514 group as compared to none in placebo.

Logs were observed and the 200 milligram 400 milligram and.

And placebo groups respectively.

And with a maximum reduction and 4.2 logs and the 400 milligram group versus 0.5 logs and the placebo group.

More patients receiving edp 5.1 and 4 had HBV DNA below the lower level of quantitation compared to none who received placebo.

Additionally, and mean reductions and HBV RNA of 2.92, 0.4, and 0.3 logs were observed and the 200 milligram 400 milligram and placebo groups, respectively with a maximum reduction of 4.8 logs with Edp 514 versus 1 point or 1.9.

Logs with placebo.

HBV RNA was undetectable at day, 28, and 8 patients and that 5.1 for group as compared to none and placebo.

Jay R. Luly: Furthermore, EDP 514 was shown to be safe and well tolerated in this patient population. This study provides important clinical evidence of EDP 5-1's 4's safety profile, as well as kinetics of viral inhibition when used as a single agent over 28 days, and is a significant advance in our efforts to deliver an all-oral functional cure for hepatitis B. Building on that success, we also recently reported positive 28-day data from the first two cohorts, 200 and 400 milligrams, of our Phase 1B study of EDP 514 and nuke suppressed chronic HPV page Importantly, these 28-day data demonstrate that EDP 514, when combined with a nuke, is safe and well-tolerated.

Further edp 514 was shown to be safe and well tolerated and this patient population.

This study provides important clinical evidence of edp 5 ones for safety profile as well as kinetics and viral inhibition when used as a single agent over 28 days and is the significant advance and our efforts to deliver an all oral and functional cure for hepatitis B.

Well then on that success. We also recently reported positive 28 day data from the first 2 cohorts 204 hundred milligrams of.

Our phase <unk> study of Edp, 504, and nuc suppressed chronic HBV patients.

And importantly.

These 28 day data demonstrate that Edp 514, when combined with a nuke is safe and well tolerated.

Jay R. Luly: Additionally, EDP514 demonstrated reductions in HPV RNA, along with the pharmacokinetic profile supported by a once daily dose. Together, these data support development of EDP 514 in combination with a nuke as a two-drug foundation on which to add other agents such as EDP 721. Such an all-oral combination therapy is a differentiated approach that could potentially lead to a functional cure for patients with chronic HPV.

Additionally, edp 5.1 demonstrated reductions and HBV RNA, along with a pharmacokinetic profile supported a once daily dosing.

These data support development of Edp, 5.1 and 4 in combination with a nuc and say 2 drugs foundation on which to add other agents such as ETP and 721.

Such and all of the oral combination therapy is a differentiated approach that could potentially lead to a functional cure for patients with chronic HBV.

Jay R. Luly: To that end, we expect to begin dosing in the phase one study of EDP721, our oral HPV RNA destabilizer, this month. Our enthusiasm for the development of EDP721 is based in part on the pre-clinical data we presented at EASL in June. In vitro, EDP 721 potently reduced HB surface anogen with pangenotypic HB activity through its selective inhibition of PAPD5 and

And that and we expect to begin dosing and the phase 1 study of Edp 721, our oral HBV RNA Destabilizer this month.

Our enthusiasm for the development of Edp 721 is based in part on the preclinical data we presented at easel in June.

And vitro ADP 721, potently reduced HBV surface antigen with Pan Genotypic HBV activity, there and selective inhibition of Pep day, 5 and Pap day 7.

Moreover, ETP 71 showed additive to synergistic antiviral activity in vitro when combined with nukes or HBV core inhibitors, such as Edp 514.

Jay R. Luly: Moreover, EDP 721 showed additive to synergistic antiviral activity in vitro when combined with nukes or HPV core inhibitors such as EDP 514. Oral administration of EDP 721 and the AAV-HB mouse model also demonstrated favorable efficacy characteristics, inducing up to a three-log drop in the HB surface answer. These pre-clinical data are particularly exciting because effective reduction of HB surface antigen has presented a substantial challenge to achieving long-term HPV viral clearance. Moving to RSV, EDP 938, the only N inhibitor in advanced clinical development today, is currently being evaluated in three ongoing phase two studies.

Oral administration of Etp's 72, 1 and the AAV HBV mouse model also demonstrated favorable efficacy characteristics and do seen up to a 3 log drop and the HBV surface antigen.

These preclinical data are particularly exciting because effective reduction of HBV surface antigen has presented a substantial challenge to achieving long term HBV viral clearance.

Moving to RSV Edp 938, the only N inhibitor and advanced clinical development. Today is currently being evaluated and 3 ongoing phase 2 studies as a reminder, RSV is a severe respiratory infection associated with significant morbidity and mortality not.

Jay R. Luly: As a reminder, RSV is a severe respiratory infection associated with significant morbidity and mortality, not only in infants but in the elderly and immune compromised adults as well. There is no safe and effective treatment for this viral infection.

And not only and in it and and fence, but and the elderly and and immune compromised adults as well there is no safe and effective treatment for this viral infection.

Jay R. Luly: As previously mentioned, RSV, like flu, did not emerge during the most recent northern and southern hemisphere seasons due to COVID-19 mitigation measures. However, where social distancing measures have subsided, RSV has begun to reemerge, and has already been observed with recent spikes of pediatric RSV cases in Australia and parts of the United States. In fact, in June, the Centers for Disease Control and Prevention issued a health advisory to notify clinicians and caregivers about increased interseasonal RSV activity across parts of the southern United States. With this in mind, we have continued to establish additional trial sites in North America, Europe, Asia Pacific, and the Southern Hemisphere.

So we previously mentioned and RSV like flu did not emerge during the most recent northern and southern hemisphere seasons due to COVID-19 mitigation measures.

However, where social distancing measures have subsided RSP has begun to reemerge and has already been observed with recent spikes of pediatric RSV cases, and Australia and parts of the United States and in fact in June and the centers for disease control and prevention issued a health advisory to notify clinicians and.

Caregivers about increased inner seasonal RSV activity across parts of the southern United States with this in mind. We have continued to establish additional trial sites in North America, Europe Asia Pacific and the southern Hemisphere.

These efforts will be key to our recruitment and our RSV clinical program, which includes RSVP, our phase <unk> study evaluating edp 938, and adults with accumulated community acquired infection.

Jay R. Luly: These efforts will be key to our recruitment in our RSV clinical program, which includes RSVP, our Phase 2B study evaluating EDP 938 and adults with a community-acquired infection, RSVTX, a phase 2B study evaluating 938, an adult hematopoetic cell transplant recipient, and RSB Peds, a phase two study in pediatric RSV patients. Given that the recent reemergence of RSV is not following any normal seasonal pattern, it's very difficult to predict how significant or sustained the new incidence of RSV will be moving forward.

RSV T X.

<unk> study evaluating and 93, 8 and adult Amanda poetic cell transplant recipients and.

And RSP Peds phase 2 study in pediatric RSV patients.

Given that the recent reemergence of RSV is not falling any normal seasonal pattern, it's very difficult to predict how significant of course and staying the new incidence of RSV will be moving forward. Nonetheless, we are more hopeful that we'll be able to complete enrollment and the RSVP study during the northern hemisphere winter season.

Jay R. Luly: Nonetheless, we are more hopeful that we'll be able to complete enrollment in the RSVP study during the Northern Hemisphere winter season, as long as there are no renewed social distancing trends. Assuming this enrollment occurs, we would expect data in the first half of 2022.

And as long as there are no renewed social distancing trends and assuming this enrollment occurs we would expect the data and the first half of 2022.

Jay R. Luly: As for RSVTX and RSVPs, which were initiated more recently than RSVP, we will continue to monitor the situation and update as appropriate. Beyond EDP 938, our other two respiratory virus discovery initiatives targeting RSV and human metanumovirus are also showing promise during lead optimization. RSVL inhibitors are another drug class that blocks viral replication.

As for RSV, TX and RSP Peds, which were initiated more recently than RSVP, we will continue to monitor the situation and update as appropriate.

Beyond Edp 938, our other 2 respiratory virus discovery initiatives targeting RSV and human Metapneumovirus are also showing promising promise during lead optimization.

RSV Ellen inhibitors, or another drug class that block viral replication and could potentially be used alone or in combination with other agents such as 93.8 to possibly broaden the treatment window, where addressable patient population.

Jay R. Luly: It could potentially be used alone or in combination with other agents such as 938, possibly broadening the treatment window or addressable patient population. As for HMPV, we believe this initiative is a natural adjacency for us, as the virus is very similar to RSV. HMPV has been shown to have worldwide circulation with nearly universal infection by age five. Adults at highest risk include the elderly, adults with underlying pulmonary disease, and those who are immune compromised.

As for H M. P. D. We believe this initiative is a natural adjacency for us as the virus is very similar to RSV.

<unk> has been shown to have worldwide circulation with nearly universal infection by age 5.

Adults at highest risk and include elderly adults with underlying pulmonary disease and.

Those who are immune compromised.

By year, and we hope to nominate another clinical candidate for me there are H M P b or RSV L inhibitor initiatives.

Jay R. Luly: By year-end, we hope to nominate another clinical candidate from either our HMPV or RSV-L Inhibitor Initiatives. Finally, I'll end with a summary of our work in Nash, a liver disease with a significant unmet need, where we are conducting clinical studies of two FXR agonists, EDP 305 and EDP 297. Recruitment and dosing in Argon 2, or a Phase 2B study of UDP-105 and patients with biopsy-proven Nash with progressive fibrosis

Finally, I'll end with a summary of our work and Nash and liver disease with a significant unmet need.

We are conducting clinical studies of 2 FX, our agonist and Edp 305, and Edp 297.

Recruitment and dosing and Oregon to our phase <unk> study of Edp 305, and patients with biopsy proven Nash with fibrosis is progressing.

Jay R. Luly: Later this quarter, we'll have a planned internal interim analysis based on 12 weeks of treatment and a subset of patients from this study. Also later this quarter, we expect to report data from a phase one first in human study of our follow-on FXR agn candidate, EDP 297. We anticipate that the combined data from this phase one study and the EDP 305 internal interim analysis will enable us to determine next steps, such as potential partners and combination approaches for our Nash program.

Later this quarter, we will have a planned internal interim analysis based on 12 week of treatment and a subset of patients from the study.

Also later this quarter, we expect to report data from a phase 1 first and human study of our follow on FX or agonist candidate Edp 297.

We anticipate that the combined data from this phase 1 study and the Edp 305 internal interim analysis will enable us to determine next steps such as potential partnering and combination approaches for our Nash program.

Before moving to our financials I'd like to highlight our upcoming milestones, which we believe position us for a strong remainder of the year.

Jay R. Luly: Before moving to our financials, I'd like to highlight our upcoming milestones, which we believe position us for a strong remainder of the year. For COVID-19, we've nominated EDP 235 as our lead oral protease inhibitor and expect to initiate a clinical study in early 2022. In HB, we plan to dose the first patient in the Phase 1 clinical study of EDP 721 this month. In Nash, we look forward to preliminary data from the Phase 1 study of EDP 297 later this quarter and determination of next steps for our Nash program following an internal interim analysis of Argon 2.

For COVID-19, we've nominated Edp 235, and it's our lead oral protease inhibitor and expect to initiate a clinical study in early 2020.2.

And HBV, we plan to dose the first patient and the phase 1 clinical study of Edp 721, this month and.

Nash, we look forward to preliminary data from the phase 1 study of Edp 297 later this quarter and determination of next steps for our Nash program following and the internal interim analysis of argon 2.

Finally, we continue to be excited about the early prospects coming out of our 2 other respiratory virology discovery initiatives and are eager to name a new clinical development candidate for RSV or human Metapneumovirus by year end.

Jay R. Luly: Finally, we continue to be excited about the early prospects coming out of our two other respiratory virology discovery initiatives and are eager to name a new clinical development candidate for RSB or human metanumovirus by year end. I would also like to take a moment to thank Dr. Nautiliana, Senior Vice President, Chief Medical Officer, for her dedication to the company over the last six years, during which she built and led the clinical development and regulatory team and helped advance our pipeline candidates.

I would also like to take a moment to thank doctor and not only at a senior Vice President and Chief Medical Chief Medical Officer for her dedication to the company over the last 6 years, bringing on.

And what she built and led the clinical development and regulatory team and helped to advance our pipeline candidates has announced her retirement is planned for February and we wish her the best we're thankful that she is staying with us on a consulting capacity thereafter.

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

Jay R. Luly: As announced, her retirement is planned for February, and we wish her the best. We're thankful that she is staying with us in a consulting capacity thereafter. With that, I'll stop here and turn the call over to Paul to discuss her financials for the quarter.

Thank you Jay I would like to remind everyone that and annual reports on a September 30th fiscal year schedule. Today, we are reporting results for our third quarter ended June 32021.

For the quarter total revenue was $21.6 million and consisted of royalty revenue earned on average callable Maverick net product sales.

This compares to total revenue was $18.7 million for the same period and 2020.

Paul J. Mellett: Thank you, Jay. I'd like to remind everyone that Ananta reports on a September 30th fiscal year schedule. Today, we are reporting results for our third quarter on June 30th, 2021. For the quarter, total revenue was $21.6 million, and it consisted of royalty revenue earned on Abbey's Global Maverit net product sales. This compares to total revenue of 18.7 million for the same period in 2020. The increase in royalty revenue compared to the same period last year was driven by higher HCV product sales as treated patient volumes increased compared to the third quarter of last year when the COVID-19 pandemic began.

The increase and royalty revenue compared to the same period last year was driven by higher HCV product sales is treated patient volumes have increased compared to the third quarter of last year on the COVID-19 pandemic began.

HCV product sales continued to remain below pre COVID-19 levels as a residual impacts from the pandemic continues.

Royalty revenue was calculated on 50% of Maverick sales and royalty rate for the quarter of 10% after adjustments for certain contractual discounts rebates and set us which are now approximately 2% of that lease total reported HCV product sales.

You can review, our royalty tier schedule and our 2020 form 10-K.

Paul J. Mellett: HV product sales continue to remain below pre-COVID levels, as a residual impact from the pandemic continues. Royalty revenue is calculated on 50% of Maverett sales at a royalty rate for the quarter of 10% after adjustments for certain contractual discounts, rebates, and set-offs, which are now approximately 2% of Abbey's total reported HCV product sales. You can review our royalty tier schedule in our

Moving on to our expenses and the 3 months ended June 32021 research and development expenses and expenses totaled $47 million compared to $34.7 million for the same period and 2020.

The increase was primarily due to the timing of our clinical trials year over year.

General and administrative expense for the quarter was $8.4 million compared to $6.8 million for the same period and 2020.

The increase was due to an increase in head count and compensation expense.

Paul J. Mellett: 2020 form 10K. Moving on to our expense,

And that's a recorded an income tax benefit of $9.4 million and the 3 months ended June 30th 2021.

Paul J. Mellett: For the three months ending June 30th, 2021, research and development expenses totaled

Appeared to and income tax benefit of $7.1 million from the same period and 2020.

Paul J. Mellett: is totaled 47 million, compared to 34.7 million for the same period in 2020. The increase was primarily due to the timing of our clinical trials year over year. General and administrative expenses for the corridor were 8.4 million, compared to 6.8 million for the same period in 2020. The increase was due to an increase in head count and compensation expenses. An entity recorded an income tax benefit of $9.4 million for the three months ending June 30, 2021.

These income tax benefits would due to the provisions of the cares Act of 2020, which enables the company to fiscal 2021to carry back as projected current year tax losses to offset taxable income and prior years.

Net loss for the 3 months ended June 30th 'twenty, 'twenty, 1 was $24 million or a loss of $1.19 per diluted common share.

<unk> to a net loss of $14.3 million or a loss of 71 cents per diluted common share for the corresponding period in 2020.

And anti ended the quarter with approximately 373 million and cash and marketable securities.

Paul J. Mellett: compared to an income tax benefit of $7.1 million for the same period in 2020.

We expect that our current cash cash equivalents and short term and long term marketable securities as well as our ongoing royalty revenue.

Paul J. Mellett: These income tax benefits are due to the provisions of the CARES Act of 2020, which enables the company through fiscal 2021 to carry back its projected current year tax loss to offset taxable income in prior years. The net loss for the three months ended June 30, 2021, was $24 million, or a loss of $119 per diluted common share, compared to a net loss of $14.3 million, or a loss of 71 cents per diluted common share for the corresponding period in 2020, and then ending the quarter with approximately $373 million in cash and marketable security.

And to be sufficient to meet the anticipated cash requirements of our existing business and development programs for at least the next 2 years.

Further financial details are available and our press release and will be available and our quarterly reports on form 10-K when filed.

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

We will now begin our Q&A session to ask a question you will need to press star 1 on your telephone to withdraw your question press the pound key.

Your first question will come from Brian <unk> with Baird. Please proceed.

Paul J. Mellett: We expect that our current cash and cash equivalence, 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.

Hey, good afternoon, guys. Thank you so much for taking the question. So I really want to talk about Edp 938, and and was wondering if you could kind of give us some compare and contrast on the phone and say if it's protease inhibitor with.

Paul J. Mellett: business and development programs for at least the next two years.

And that's what ear and and maybe Pfizer's P I and and can you do effective cereal passage studies with Sars Covid 2 models and can you comment on at all on on what sort of resistance you can induce and then just on the safety front and what sort of room do you have on selectivity index before you start hitting on some of the human proteases and unseen cytotoxin.

Paul J. Mellett: Further financial details are available in our press release and will be available in our quarterly report on Form 10k when filed. I'd now like to turn the call back to the operator and open up the lines of questions.

Operator: We will now begin our Q&P.

Operator: day session. To ask a question, you will need to press star 1 on your telephone. To withdraw your question,

Oh, Hi, Brian This is Jay So I think he meant edp 235, not edp 9 sorry.

Operator: your question, press the pound key. For your first question

Brian Peter Skorney: Your first question will come from Brian Skorkney with Baird. Please continue. Hey, good afternoon, guys. Thank you so much for taking the time to answer my question.

And.

So anyway, ADP 235, the service growth too.

These inhibitors that we announced today.

Serial passenger I mean, we don't have the.

Brian Peter Skorney: I really wanted to talk about EDP 938 and was wondering if you could kind of give us some comparisons and contrasts on the potency of the protease inhibitor.

Sars Covid 2 virus and house, so we rely on external.

Providers for some of those.

Cranes on studies, but we do do.

Brian Peter Skorney: you know, Rendesivir and maybe Pfizer's PI, and can you do effective serial passage studies with SARS-CoV-2 models, and can you comment at all on what sort of resistance you might see?

And so worst looking at resistance in house.

But we use.

Model Corona's Oh.

Our work.

Brian Peter Skorney: induce, and then just on the safety front, what sort of room do you have on the selectivity index before you start hitting some of the human proteases and see cytotoxin?

And so to that and 1 of the profile that we've generated so far internally books.

And we've already model.

And so we were excited by.

Not only that.

Jay R. Luly: Hi Brian, this is Che. So I think you meant EDP 235, not EDP 938. Oh, sorry, I have to. So anyway, ADP 235, the SARS-Cope 2 production inhibitor that we announced today. You know, cereal passages. We don't have the live SARS-Cope 2 virus in-house, so we rely on external providers for some of those kinds of studies, but we do do, you know, extensive work looking at resistance in-house, but we use model coronas for that work.

Net attribute but obviously also the.

Potency that we have there I think when you look on a candidate.

With the way, we look and a candidate.

Oh versus others that are out there just even where we put the low.

Mark on the map for what we're trying to hit.

We obviously want to drill down on on potency and look at that and lots of different ways. You know we reported good data and primary human airway epithelium cells, which is a great way to look.

We also look at activity against variance and and.

We're pleased with the profile that we've seen there talked about the material passengers that we've done.

Jay R. Luly: And so to that end, you know, the profile that we've generated so far internally looks, looks very, very nice. And so we were excited by, not only that attribute, but obviously also the potency that we have there. I think, you know, when you look at a candidate, at least the way we look at a candidate versus others that are out there, just even, you know, where we put the mark on the map for what we're trying to hit, you know, we obviously want to drill down on potency and look at that in lots of different ways. You know, we've reported good data and primaries. Human airway epithelial cells, which is a great way to look.

And then getting on to a sale.

Safety and I Couldnt Queen and.

We look we do you know sort of extensive safety work prior to taking any of our candidates and we feel very comfortable with the safety pack.

Package that we put together.

For this candidate.

And given the potency and the wide window as we don't expect any.

And that's sort of complications going into our clinical studies.

With this molecule.

But what can be on that these are sorted and said.

On the meat and potato things, but we pushed it and looked at even further as you know we we.

Jay R. Luly: We also look at activity against variants, and we're pleased with the profile that we've seen there, talking about the serial passages that we've done. And then getting on to safety, I think we look, we do, you know, sort of extensive safety work prior to taking any of our candidates, and we feel very comfortable with the safety package that we've put together for this candidate. So I, given the potency and the wide windows, we don't expect any, you know, sort of complications going into our clinical studies with this molecule.

And we're always looking at tissue.

And targeting and tissue distribution, whether it's with our opex or whether it's with our hepatitis drugs.

And you.

And sorry, I spoke to is no exception, we we saw very good tissue distribution and and looked at our long levels on rodents very pleased with that.

That profile and also having surveyed PK across multiple different species, we feel pretty confident.

Since the QD.

Dosing drugs so.

It's really the aggregate of all these things put together you can put a punctuation together and.

Jay R. Luly: But looking beyond that, these are sort of the meat and potatoes things, but we pushed it and looked even further. As you know, we're always looking at tissue targeting and tissue distribution, whether it's with our FXR, whether it's with our hepatitis drugs, And, you know, SARScope 2 is no exception. We saw very good tissue distribution and looked at lung levels in rodents. We are very pleased with that profile. And also, having surveyed PK across multiple different species, we feel pretty confident that this is a QD dose and drug. So it's really the sum of all these things put together.

You know check cash mine is it 10, but.

We werent down until we check every every box, we worry you mean to do well and the.

And those candidates and I think the other sort of exciting aspect of this since we have.

And then activity against other Corona viruses with us as well so theres stuff.

And the possibility that we could go beyond serves quote 2 here on Kona.

About.

And our readiness for other pandemic virus and sort of the Corona virus and so all in and so very exciting and candidate and.

And suites.

And as we've mentioned we're on track.

To initiate clinical studies really not sure.

Great. Thanks for taking my question Jay.

Youre welcome.

Your next question will come from Yasmin Rahimi with Piper Sandler. Please please feed.

Hi, Good evening. This is swapped and Alon for I guess, a couple of questions first of Florida, 7 coupon should we expect to see the 800 milligram cohort data it is and the.

Jay R. Luly: You can put a punch list together, you know, check nine is a 10, but, you know, we weren't done until we checked every box we were aiming to check in this candidate. I think the other sort of exciting aspect of this is that we have seen activity against other coronaviruses with this as well, so there's the possibility that we could go beyond SARS-Cote 2 here and think about, you know, readiness for other pandemic viruses or other coronaviruses. All ends up a very exciting candidate. As we've mentioned, we're on track to initiate clinical studies early next year.

And then based upon your incremental PK PD modeling work, how much additional HBV DNA and bent knockdown and benefit do you expect to see or what are the perfect 204 hundred milligram doses.

Oh, I think I think you've got accounts.

On number mixed up to I think you said on Edp 7 to 1 and I think you were referring to Edp 514.

Jay R. Luly: Great, thanks for taking the question, Jeff. You're welcome. Your next question will come from Yasmin Rahimi with Piper Sandler, please, please, please.

Of course interest rates side, yes.

Yeah, well, we have I know, we have a lot of molecules to keep track of it.

Yasmeen Rahimi: Hi, good evening; this is Swapnilon for gas. A couple of questions. First, for 7-21, should we expect to see the 800-millimeter cohort data at ASLD? And then, based upon your internal PKPD modeling work, how much additional HBD-D-Nockdown benefit do you expect to see over the reported 200 and 400-millimeter doses?

So the with regards to 5.1 and for the 204 hundred.

Milligram doses, you know, whether we were looking and nuc suppressed patients or or and <unk> patients.

Both of them showed.

Very good.

Performance.

Not only on terms of safety and PK, which as you know 1 of the main things we were looking for but also and of course of the nuc suppressed and the only wanted to make sure, but our molecule behaved well.

Yasmeen Rahimi: Yeah, I think you've got a count on numbers mixed up. I think you said EDP 721, and I think you were referring to EDP 514, the core. Yeah, that's right.

With a nuke right Nicholas and wanted to set the foundation of a 2 drug combo on which to all the other molecule you mentioned 7 to 1 Mike on the whole world Triple.

Jay R. Luly: Yeah, I know we have a lot of molecules to keep track out there. So with regards to 514, you know, the 200 and 400, milligram doses, you know, whether we were looking at nuke suppress patients or by remit patients, both of them showed, you know, very good performance, not only in terms of safety and PK, which is, you know, one of the main things we were looking for, but also in the case of the nuke suppressed, you know, we wanted to make sure that our molecule behaved well with a nuke, right?

So.

I think we got.

Based on the virology that we saw.

At the 204 hundred.

But and you look at DNA or RNA, and whether you looked at that 1 patient population.

Or the other we saw good safety and and Goodbye rheology as we would've expected from each of those different patient populations.

And on that.

And that's what really sets the stage for moving ahead I think the 800.

What we see there on top of that we saw such significant exposure at 204 hundred.

Jay R. Luly: because we wanted to set the foundation of a two drug combo on which to add the other molecule you mentioned 721 to make an all oral triple, so, um, based on the virology that we saw at the 200 and 400, whether you looked at DNA or RNA, whether you looked at one patient population or the other, we saw good safety and good virology as we would have expected in each of those different patient populations, and it definitely sets the stage I think the 800. You know, what will we see on top of that?

You know, it's not clear that any more exposure will give you any more benefit.

But of course, so we'll pull that data in and see it and we will.

We'll put it out it.

You know whatever the next appropriate.

Sort of major scientific conferences.

And do that and so stay tuned on.

On that front, but again I think we've we've seen and what we need to see already to know that type 1 and for cars.

Great anti viral attack are great.

And safety and Tolerability profile and soon to date and HBV patients a day.

Thanks.

And.

And a good 2 drug foundation with the Nuc to set the stage for a triple with Eaton and 7 to 1.

Jay R. Luly: We saw such a significant exposure at 200 and 400. You know, it's not clear that any more exposure will give you any more benefit, but of course, we'll pull that data in and see it, and we'll put it out at, um, whatever the next appropriate major scientific conferences to do that at. So stay tuned on that front. But again, I think we've seen what we need to see already to know that 514 has a great antiviral effect, a great safety and tolerability profile to seem to date in HB patients up to 28 days, and a good two-drug foundation with the nuke to set the stage for a triple with E.P.71.

Okay, Great I had 1 follow up question. So for 235 work and gating factors on remaining better you guys in terms of.

Regulatory pathway before you initiate the phase 1 trial and credit card income.

Yeah, I'd say that you know what I mean, all the R&D, enabling studies are done so were classic gene you know that that sort of stuff off we're procuring drug supply and we're doing all of those kinds of things in terms of readiness.

And as we prepare for it.

You know the phase 1 study and I was just sort of routine stuff at this point.

Great. Thank you for taking my questions.

Your next question will come from Brian Abrahams with RBC capital markets. Please proceed.

Yasmeen Rahimi: Okay, great. I had one follow-up question. So for two, three, five, what gating factors are remaining? Where are you guys in terms of the regulatory pathway before you initiate the phase one trial in 2020-2021?

Hey, guys. Congrats on the progress thanks for taking my questions and my congratulations and best of luck to a doctor out on how to.

On retirement.

First question on the 235, maybe a bigger picture question I was wondering if you could maybe talk about how youre thinking about next steps here and phase, 1 and and beyond for the for the program. What you think the clinical path might look like and is this something where you might expect a P I alone to be adequate.

Yasmeen Rahimi: Yeah, I'd say that, you know, all the I and D enabling studies are done, so we're packaging, you know, that sort of stuff up, we're procuring drug supply, we're doing all those kinds of things in terms of readiness as we prepare for the..., you know, the base one study, but it's just sort of routine stuff at this.

Or do you think this could be more akin to HIV or or Hep C, where you'd want to combine this with other classes of direct acting antivirals like nukes.

Yasmeen Rahimi: Great. Thank you for taking a question.

Well you know it's a good question Bryan we we.

Brian Corey Abrahams: Your next question will come from Brian Abrams with RBC Capital Markets. Please proceed.

No. The answer is nobody really knows but that said, we're talking about and acute infection. Here. So I think we're pretty encouraged that day.

Brian Corey Abrahams: Hey guys, congrats on the progress. Thanks for taking my questions and my congratulations and best of luck to Dr. Otto in his retirement.

A single agent could be enough.

And.

And obviously when we set up this program.

Brian Corey Abrahams: First question on 235, maybe a bigger picture question. I was wondering if you could maybe talk about how you're thinking about, you know, the next steps here, phase one and beyond for the program, and what you think the clinical path might look like. And is this something where you might expect a PI alone to be adequate, or do you think this could be more akin to, you know, HIV or HFC where you'd want to combine this with other classes of the direction? direct acting in some of our rules like New Well, you know, it's a good question, Brian.

And now at the beginning of the pandemic, we didn't work just on most of them up on those on.

And I have been on and continue to be working on other map and maintenance.

And just because you never know what could happen here.

Down the road with regards to borrow on sort of anything else, but from what we see.

I think we would be very and.

You know encouraged to take a protease and.

And see you know.

And the impact on.

Yeah, hopefully viral loads and sometimes you know very quickly these mechanisms are.

Are you now sort of tried and true DAA lots and lots.

Hum.

We certainly don't know yet that we would need to go in with combination therapy.

You might.

We expect to do and from hepatitis C or certainly on hepatitis B. So.

As you know with RSV, we're looking up.

Short term treatment with <unk>.

Jay R. Luly: We, we... The answer is nobody really knows, but, you know, that said, we're talking about an acute infection here, so I think we're pretty encouraged that a single agent could be enough. Now, obviously, when we set up this program, you know, at the beginning of the pandemic, we didn't work just on this mechanism. We have been and continue to be working on other mechanisms just because you never know what could happen here, you know, down the road with regard to variance or anything else.

And with our RSV drag as a mono agent.

But again for that program looks like with some stuff to work, we're gonna click multiple approaches.

Just because of the and you know if we can come up with and even better approach on the line that'd be great with combinations with needed down the line.

We want to be and we're positioned to potentially.

Potentially multiple.

Quality assets.

That's why we continue.

Boring and RSV nowhere and multiple.

And these studies with a very promising agent you know kind of help us for example get into different patient populations that you might not otherwise be able to get into COVID-19 allow us to.

Jay R. Luly: But from what we see, I think we would be very, you know, encouraged to take a protease in and see, you know, an impact on, you know, hopefully viral loads and symptoms. Very quickly, these mechanisms are or, you know, sort of trying to include DAA mechanisms.

And treat more severe ah patients are broad and the treatment window and these are all questions that we can ask them in due course.

But you know 1 of the things and have just from a paradigm and general that.

And we've thought about RSV.

Sort of the.

The Holy Grail here is early diagnosis and rapid treatment and you've heard me talk about that concept now for multiple years and connection with RSV.

Jay R. Luly: And we certainly don't know yet that we would need to go in with combination therapy, as you might expect to do in hepatitis C or certainly in hepatitis B. So, as you know, with RSV, we're looking at short-term treatment with our RSV drug as a mono agent. But again, for that program, just like Sarscope 2, you know, we're going to take multiple approaches. Just because, at the end, you know, if we can come up with an even better approach down the line, that'd be great if combinations are needed down the line. You know, we want to be in the position to have potentially multiple quality assets.

We believe that plays and human Metapneumovirus or we were talking about that.

Just before the pandemic launched and now with Sars Covid, 2 we think that possibly tux and.

And there as well so again nothing and so we've been stating this sort of approach and our goal for a long time now with different viruses and I think a lot of people now.

But the sort of the vaccine visibility has claws a run on.

Jay R. Luly: That's why we continue, you know, exploring an RSV, even though we're in multiple phase three studies with a very promising agent. You know, can it help us, for example, get into different patient populations that you might not otherwise be able to get into? Could it allow us to, you know, treat more severe patients or broaden a treatment window? These are all questions that we can, you know, ask and do, of course.

Of course for a while now people are starting to think about and wonder about and worry about the lack of.

Jay R. Luly: But, you know, one of the things, you know, just from a paradigm in general, if we thought about RSV, you know, sort of the, you know, the holy grail here is early diagnosis and rapid treatment. You've heard me talk about that concept for multiple years in connection with RSV. We believe it applies in human metanumovirus, where we were talking about that. Just before the pandemic launched and now with SARS-Cope 2, we think that possibly techs are there as well.

Jay R. Luly: So, you know, again, this is, we've been stating this sort of approach and goal for a long time now with different viruses. And I think a lot of people now that the visibility of the vaccine has run its course for a while now, people are starting to think about and wonder about and worry about the lack of therapeutics. And to that end, I think a lot of people are thinking it would be wonderful to have something that if you, you know, are symptomatic, you go to CVS, you get a swab, you're positive, and you get treated as an outpatient with an easy-to-use, safe oral drug that you just go home, knock that viral load down, stop the shedding, get back to work. So that's So I hope that that helps.

Alright, and I I saw your note earlier this week that and and we've been pointed it out to that you know first starting and and the southern Hemisphere, you know once summer rolled around and this summer while we were and winter it was becoming summer and the southern hemisphere and the masks started to drop a little.

<unk> and Australia, and and I saw this is huge pediatric spike and are seasonal spike and then we were quietly thinking well. That's you know it could well happen here uhm.

Uhm and guess what it did did start to happen and you have a few weeks ago and the C. D. C said, there's been this big uptick on enter seasonal.

Brian Corey Abrahams: Yeah, no, that's really helpful, Jay, thanks. And then maybe one more on 938. I know you've been continuing to expand and mobilize.

R. S V and some spots, it's been and certain southern parts of the United States, where these things and I was sort of pop up so we've got sites all over the place and so you know we have seen some some upticks and that's why you know we are cautiously off.

Brian Corey Abrahams: You've been continuing to expand and mobilize your sites. I'm curious to what degree you've been able to take advantage of the recent off-season RSV spikes. Is there, I guess, how much consistency is there regionally with where these spikes are and where your trial sites are? And is there any Are there any changes in the way you might screen or even monitor patients in an off-season RSV surge versus the normal seasonal upt

Domestic that if that's trends continue and we go into the winter season here that we should be able to to wrap up.

You know the R. S V P study.

And cheese and and and if that's the case and you know we would have data and the first half and.

Jay R. Luly: Yeah, we're pretty spread out geographically in the U.S. and globally. You are correct, and I saw your note earlier this week, and we've been pointing to that too, that, you know, first starting in the southern hemisphere, once summer rolled around in the southern hemisphere, while we were in winter, it was becoming summer in the southern hemisphere, and the masks started to drop a little bit in Australia, and they saw this huge pediatric spike, an interseasonal spike. and then we were quietly thinking, well, that could, you know, could well happen here. And guess what?

Of next year, well, what I think we really need to see is you know are these little inner seasonal spikes and just kinda you know tamped down all day.

Jay R. Luly: It did start to happen. You know, a few weeks ago, the CDC said there's been this big uptick in interseasonal RSV in some spots. It's been in certain southern parts of the United States where these things, you know, sort of pop up. So we've got sites all over the place.

Jay R. Luly: And so, you know, we have seen some upticks, and that's why, you know, we are cautiously optimistic that if trends continue and we go into the winter season here, that we should be able to wrap up the RSVP study this season, and if that's the case, then, you know, we would have data in the first half of next year. But what I think we really need to see is, you know, are these little interseasonal spikes just kind of, you know, camp down?

Jay R. Luly: Are they... Are they going to camp down and then come roaring back in the fall and winter months when RISB is normally prevalent? I mean, there's every expectation that, and you start to hear about it on the news, you know, these other, you know, yet another respiratory virus that people should have on their minds. We don't have enough to think about with COVID. But we're starting to hear more and more that awareness for RSA is coming back, and the testing is coming back.

Jay R. Luly: The CDC recommends that just because somebody has sometimes doesn't assume that they have SARS and if they're SARS Code 2 negative, you know, get tested for RSV anyway. So this is a way we're going to start to figure out, um, you know, where these real patterns are. But we've got our catchersmith on, and we've got lots of sites around, and so as patients come in, we'll be, you know, ready to grab them.

And what to assume that we do extensive benchmarking and.

Across all kinds of parameters with every molecule that we can lay our hands on and.

And and we've done that with 235.

And and kind of along the same lines are you gonna and.

Present, or publish either preclinical or chemical data and.

And before the phase 1 results or the face 1 results gonna be the first we're gonna see data.

Douglas Royal Buchanan: Your next question will come from Roy Buchanan with JMP Securities. Please proceed.

So there there might be.

Douglas Royal Buchanan: Hi, great. Thanks for taking the questions. I had a couple on 235, I guess. So this is, you know, the structure of Pfizer's lead oral inhibitors out there. I'm just curious if you guys did any side-by-side comparisons, you know, in view of potential differences between assays and if you have a side-by-side comparison of the potency. And then can you tell us if 235 is covalent? Is it reversible?

You know, we'll we'll see you were talking about putting out preclinical data of some sort.

Uh-huh hoster of paper right Yeah, Yeah, we're we're working on that strategy.

Internally I think.

And on the 1 hand, it's.

Exciting to to go on.

And what these kinds of bits of information from various public aura, but we're we're really focused on mobilizing and and pushing ahead to get ourselves and at the clinic and and then ultimately get into.

No clinical later stage clinical studies as fast as we can so but the day to will come out and do of course.

Douglas Royal Buchanan: and that's the follow-up.

Jay R. Luly: Yeah, no, I know exactly the kinds of questions you're asking. It's just the kinds of questions I usually don't answer until we're ready to answer them.

Okay got it and I had a few on 721 and was looking at the clinical trials Dot Gov record I see the 1 side and New Zealand I guess, if they're gonna be additional sites added and.

Douglas Royal Buchanan: But it's fair to assume that we do extensive benchmarking across all kinds of parameters with every molecule that we can lay our hands on, and we've done that with 2, 3, 5. Okay, and then kind of

And I didn't see any breakdown of the number of patients and the virus and making a nuke suppressed groups can you give us a sense of what that.

Target breakdown is if there is 1 and.

And then I have a few more questions.

Yeah. So.

Douglas Royal Buchanan: Okay, kind of along the same lines. Are you going to present or publish either pre-clinical or chemical data before the phase one results, or is the phase one result going to be the first we're going to see? So there might be, you know, we'll

And Ah right now or.

We let's see.

Sort of had and are prepared remarks, and and and the release.

Uhm 9721 study has been initiated for screening now where expecting to dose you know this month so.

Douglas Royal Buchanan: You know, we'll see, you're talking about putting out pre-clinical data of some sort. Right, like a poster or a paper.

No lettuce uhm, let us do the.

The study.

And we'll report more details on our on our clinical trial design on and.

Douglas Royal Buchanan: Yeah, yeah, we're working on that strategy internally. I think, uh, on the one hand, it's exciting to put these kinds of bits of information out in various public fora, but we're really focused on mobilizing and pushing ahead to get ourselves into the clinic and then ultimately get into later stage clinical studies as fast as we can. So, the data will come out in due course.

And how we're gonna quit.

Put those triple combo, together et cetera, et cetera will more details on that and a later time.

[laughter], Okay fair enough. So you probably want answered my other question theater, but I didn't see you have the combo with 514 already and their trial and.

Design, so that's exciting and.

Alright, I guess I'll ask away on 1 last question on a different topic, so Nash and I'll take the current programs, but you guys have talked about it and novel mechanism for some time and I'm. Just curious you know when you might disclose the target or the pathway just any any news there. Thanks.

Douglas Royal Buchanan: Okay, I got it. And I had a few on 721.

Douglas Royal Buchanan: I was looking at the Clinical Trials.gov record. I see one side in New Zealand. I guess there are going to be additional sites added. And I didn't see any breakdown of the number of patients in the Vyremic and the Nuk suppressed groups. Can you give us a sense of what the target breakdown is if there is one, and then I have a few more

Yeah. So.

We we obviously haven't prepared to disclose at target.

And program this quarter, but I I think that's fair to say you know, we just got on a lot and Nash all coming together here and the next you know a little bit and I think this quarter will be really interesting for US says, we're pulling and no or internal interim read on Oregon too.

Douglas Royal Buchanan: Yeah, so, as we, as we sort of had in our prepared remarks and the release, the 721 study has been initiated. We're screening now; we're expecting to dose this month. So, you know, let us do this study. And we'll report more details on our clinical trial design on how we're going to put this triple combo together, et cetera, et cetera. We'll have more details on that. Okay, fair enough.

We'll have changed 1 day, though on our other effects, alright, goodness meat and 297.

You know with the Oregon too I E. You know our hope is to.

The figure out what are the appropriate doses that we can peel off and then and entertain combination studies with perhaps on the context and a partnership and.

<unk> et cetera, [noise] so.

Suffice it to say we're thinking about.

And this quarter, and and Nash and and and a big picture sort of way and even if we were thinking of you know ultimately.

Douglas Royal Buchanan: Okay, fair enough. So you probably won't answer my other questions either, but I didn't see you have the combo with 514 already in the trial design, so that's, um, All right, I guess I'll ask one last question on a different topic. So Nash, not the current programs, but you guys have talked about a novel mechanism for some time. I'm just curious, you know, when you might disclose the target or the pathway, just any news there. Um, yeah.

Teaming up on some sort of a partnership you know would we do that even with the earlier stage program. You know these are questions that we have on completely sorted out, but we're thinking through.

You know right now, but with regards to your very specific question about what is the target you know and we're not we're not prepared to to get into that today.

Okay fair enough. Thanks, Jay.

You're welcome.

And your next question will come from Lisa banker with Evercore I S. I. Please proceed.

Hi, there. Thanks for taking the question could you maybe talk a little bit about as we prepare for R. S. V. P. You know what specifically we should be looking for now and the data to and.

Jay R. Luly: We obviously am prepared to disclose that target and program this quarter, but I think it's fair to say, you know, we've just got a lot in Nash all coming together here in the next, you know, a little bit. I think this quarter will be really interesting for us as we're pulling in our internal interim read on Argon 2. We'll have phase one data on our other FSR, Agnist EEP 297.

And to make an assessment.

Sure.

Maybe I'll.

And.

Pull this question over to Natalie to comment on further but you know maybe I'll just preface it are you saying.

You know you recall or.

Alright, Human Challenge study.

Where you know human volunteers were infected with the virus you know you wait around and you're constantly monitor their viral loads and once the viral load and such a certain threshold.

Jay R. Luly: You know, with the Argon 2, IA, our hope is to figure out, you know, what are the appropriate doses that we can peel off then and entertain combination studies with, perhaps in the context of a partnership, you know, et cetera, et cetera. Suffice it to say we're thinking about this quarter in Nash in a big picture sort of way. And even if we were thinking of, you know, ultimately, teaming up in some sort of partnership, would we do that even with our earlier stage program?

And.

You began dosing and when the people began.

To receive drug they were also symptomatic with at least you know a symptom of sorts and what we saw was you know and number 1 and a very nice set of viral kinetics.

And 1 of the key things, we were looking for and that study.

Very different and placebo you know soon and he started dosing drug the course of the infection.

Jay R. Luly: You know, these are questions that we haven't completely sorted out, but we're thinking through them, you know, right now. But with regard to your very specific question about what the target is, we're not prepared to get into that. Okay, fair enough. Thanks, Jay.

You know completely change people with placebo continued to get worse and people on drugs.

You know got better that was you could you could look at that and the form of viral loads you can look at it and parallel with the same time course with People's sometimes I think and and the outpatient setting.

And.

Able to get the same frequency or viral loads I think we were doing you know went and and the challenge studied you're able to take.

Lisa Baker: Your next question will come from Lisa Baker with Evercore ISI. Please proceed. Hi there, thanks for taking the question.

And swabs twice a day I think we were doing over the course of the whole study. That's that's just not feasible and and patient's day, you said, that's not to say that we won't get any virology.

Lisa Baker: We talk a little bit about, as we prepare for RSVP, you know, what specifically we should be looking for on the day.

But what we are tracking is.

Lisa Baker: or, you know, in the data to make an assessment.

Is symptoms. So we'll have symptoms and then we'll have virology.

Jay R. Luly: Sure, maybe I'll, you know, pull this question over to Natalie to comment on further, but, you know, maybe I just will preface it by saying, you know, you recall our, um, our human challenge study, where, you know, human volunteers were infected with the virus. You wait around, you constantly monitor their viral loads, and once the viral load reaches a certain threshold, you begin dosing, and when the people began to And what we saw was, you know, number one, a very nice set of viral kinetics, one of the key things we were looking for in that study.

Uhm.

Instead of Readouts, but not only do you want to come in and further.

Sure. Thank you for your question, so [laughter] and maybe just to add to what day was saying I think there's you know I I would like to know too issue addition to that and just give me you know we want to confirm does it makes windows and the 800 milligrams and there was and.

And I says and to change that and you hear that what she comes and move on which would you be able to get to increase it. So I think it's gonna be and punching her to at least I have a good assessment and confirm that our typically do is is the 1 for the patient savings. That's 1 thing and will confirm them through uhm and color.

Jay R. Luly: Very different than placebo, you know, as soon as you started dosing the drug, the course of the infections completely changed. People with placebo continued to get worse, and people on drugs, you know, got better. That was, you could, you could look at that in the form of viral loads. You could look at it in parallel with the same time course as people's symptoms. I think in the outpatient setting, you know, we're not able to get the same frequency of viral loads.

On primary and Parliament, which is you know just sometimes cool and we want I'll just need to get out of debt saving and defending that your translation on the challenge city in and what I would say and you know I'll keep you sure.

Jay R. Luly: I think we were doing, you know, in the challenge study, you're able to take... you know, swabs twice a day, I think we were doing over the course of the whole study. That's just not feasible in an outpatient study. So it's not to say that we won't get any virology, but what we are tracking is, you know, symptoms. So we'll have symptoms, and we'll have virology as a..., as a set of readouts. But Natalie, do you want to comment any further?

And is confirm in and out it's a patient savings and we wanted to share with it as you treat patients we him and very short window that we can and and know the patient to notebook with and 2 of more severe disease and and that would be trusted.

And 2 more central on it alright.

And I, just usually it's gonna be born to get the primary and point, we waited for the city to be able to do that to eat out and we'd be neat and see if exercise and was I says for the 4 of just say is appropriate and and then we.

Natalie: Sure, hi Lisa, thank you for your question.

Natalie: So maybe just to what Jay was saying. I think there's, you know, I would make a few additions to that. Obviously, you know, we want to confirm the selected dose, the 800 milligrams that were assessed in the challenge study, you know, there were 600 milligrams that through the BA we had to increase. So I think it's going to be important, you know, to at least have a good assessment and confirm that our selected dose is the one for the patient setting. That's one thing.

We benchmark that through the chain and steady between the very quick survey.

Oh.

The city is so.

And I I I think we will be able to confirm which location on the challenge to be occupations day.

Natalie: And we'll confirm them through an important primary endpoint, which is, you know, the symptoms score. We want, obviously, to get out of that study understanding that the translation from a challenge study in a more, I would say, you know, artificial setting is confirmed in an outpatient setting. And we want to show that as you treat patients within a very short window, we can allow the patient to not progress to more severe disease, and that will translate into more symptoms.

Okay, Great and then Jay if you could talk a little bit about uhm and on your different I guess.

Potential pass you could take with and Nash program and what you're looking from the day to kind of go down those different paths <unk>, maybe you can summarize that you're thinking about it ahead and a come out and thanks.

Yeah, well I you know we've always.

You know for years, now and I think actually we've.

Natalie: This is why it's going to be important to look at our primary endpoint. We have well-powered our study to be able to do that without. We believe that the FXI that was assessed for the power of the study is appropriate, and even we benchmarked that to the challenge study, but we were very conservative in our R&P studies. I think we will be able to confirm the translation from the challenge state to the allocation state.

<unk> said that.

With regards to Nash you know.

We don't aspire to be a commercial stage Nash company and we don't aspire.

[noise] to be if he's 3 Nash company and.

Instead, we Wanna do phase to work get appropriate please 2 data points and.

And then.

No team up with a with another.

And another party.

Lisa Baker: Okay, great. And then Jay, if you could talk a little bit about,

And so I think that that's really you know how we're thinking about it the the focus on that I think you know ultimately.

Lisa Baker: about the kind of your different, I guess.

F X R.

Lisa Baker: potential paths you could take with the Nash program and what you're looking for in the data, kind of go down those different paths. Maybe you can summarize how you're thinking about it ahead of data coming out.

You know with and and the right day. So you can still make a big impact I think and and the form of combinations.

And so it will be you know again, that's why the I, a and we're gonna be getting here soon.

Jay R. Luly: Yeah, well, you know, we've always... You know, for years now, I think actually we've said that with regard to Nash, we don't aspire to be a commercial stage of Nash company. We don't aspire to be a phase three Nash company.

Is really.

Really appropriate uhm, you recall from our Oregon, 1 study and we looked at 1 milligram and 2 and a half milligrams.

Unacceptable pruritus at 2 and a half.

Jay R. Luly: Instead, we want to do phase two work, get appropriate phase two data points, and then, you know, team up with another party. And so I think that's really, you know, how we're thinking about it, the focus on that. I think, ultimately, FXR, within the right doses, can still make a big impact, I think, in the form of combination. So we'll be, you know, again, that's why the IA that we're going to be getting here soon is really appropriate. You recall from our Oregon one study, we looked at one milligram and two and a half milligrams. We saw unacceptable paritis at two and a half.

You know, it's it's sort of like and intercept you know and looked at 10 and 25, great. We looked at 1 and 2 points on.

And so Oregon too now as as as you know and <unk> and then we.

Jay R. Luly: You know, it's sort of like an intercept, you know, looked at 10 and 25, right? We looked at 1 and 2.5. And so Argon 2 now is, as you know, and I know we've had discussions about this in the past. Argon 2 is going down between those two doses just to see if there is another dose other than the 1 milligram where we did see, you know, significant target engagement. So even at 1 milligram, we saw results, but we felt like we could be leaving some efficacy on the table.

Jay R. Luly: So can we tweak it a little further, you know, extract more efficacy without pushing on a paritis button, whatever mysterious button that is? And so that's what we'll get. We're going to get that data. Again, we already know the one milligram; we know the two and a half. We're looking at data in between those points. And then that will give us some dosing information, again, for which we can peel off and do, you know, seek a certain combination of possibilities. And we would aim to do that in the context of a partnership.

Lisa Baker: Okay, great. Thank you. You're welcome. Again, as a reminder, to ask a question, you will need to press Star 1 on your telephone. Your next question will come from Jay Olson on our...

Likely to seek a role and clinical development at what point would you consider potentially identifying a potential partner and HVV. Thanks.

Jay Olson: Jay Olsen with Oppenheimer, please proceed.

Sure those are great questions Uhm, what sense and shall we we just talked about partnering and and and.

Matt: Hi, this is Matt on behalf of Jay. Thanks for taking our questions.

Nash Uhm I.

Matt: The first thing I wanted to ask was, since HBV is a large global opportunity, what are your thoughts on a potential partnership there, especially XUS, and also since a potential partner would be likely to seek a role in clinical development, at what point would you consider identifying a potential partner in HBB? Thanks.

I've <unk> I've also spoken about partnering and H B b.

And now there is a little bit different and and Nash and it's and and that and in turn and there's a little bit different on our human and a respiratory program, but let's let's talk about HBV and.

And.

And I'll contrast, it to H C V. You know when we did our H C V deal.

Jay R. Luly: Sure, those are great questions. Well, since actually we just talked about partnering, and at Nash, I've also spoken about, you know, partnering in HBV. And now here it's a little bit different than Nash, and that, in turn, is a little bit different than our human, you know, respiratory program. But let's talk about HBV. And I'll contrast it to HCV. You know, when we did our HCV deal with Abbott, which became Abbey several years ago.

With habit, which became and have the several years ago. You know, we had a protease inhibitor and and they had other assets, but neither of US had you know the combination that we needed to put together to create the all of the world cure.

This is a little different you know we do have.

Possibly any way we're assembling the agents that we hope to be.

Sufficient for and all or true right. We have next is a standard of care. So everybody sort of gets a nuke for free.

Jay R. Luly: You know, we had a protease inhibitor, and they had other assets, but neither of us had the combination that we needed to put together to create the all oral cure. Um, this is a little different.

Is that our core inhibitor, we've now and put out too good datasets on that and including the 2 drug combination with a milk.

And now we've got 721.

Jay R. Luly: You know, we do have, possibly, anyway. We're assembling the agents that we hope will be sufficient for an all oral cure, right? We have Nix as a standard of care. Everybody sort of gets a nuke for free.

You know getting ready to be dosed here you know very soon.

She'll be the third part of that uhm potential oral triple So I think what we're gonna ask is you know is that enough we'll be doing the experiments clinical trials that will help us sort out whether or not that is and off we're we're very excited by the possibility because if.

Jay R. Luly: We've got our core inhibitor. We've now put out two good data sets on that, including a two-drug combination with a nuke. And now we've got 721, you know, getting ready to be dosed here, you know, very soon, which will be the third part of that potential all-oral triple. So I think what we're going to ask is, you know, is that enough? We'll be doing the experiments and clinical trials that will help us sort out, you know, whether or not that is enough. We're very excited by the possibility because if we do, it's a highly differentiated product profile with an all-oral therapy. All-oral will always win out over a mixture of injectable and oral therapies, all things being equal.

And we do.

It's a highly differentiated product profile.

With and all oral therapy, all world will always went out over and a mixture of injectable and world therapies, all things being equal and so you know with.

Now with the advent of 721, which we announce you know just this year, we announced it within the context of the candidate and and a short and runway and to the clinic and a potent effect on S and kitchen reduction.

Jay R. Luly: And so, you know, with the advent of 71, which we announced just this year, we announced in the context of a candidate and a short runway into the clinic and a potent effect on S antigen reduction. We think we may have all those bits and pieces. So, that's, you know, the near term, right? We'll hopefully be in an... in an all-world triple trial next year. And if that data looks good, you know, you can start to think about, well, you know, whether the steps beyond that.

Think we may have all those get some pieces. So so that's that's you know the near term right will hopefully be and I.

And and all World Triple trial next year.

And if if that day to.

And it looks good you know you can start to think about well you know what are the steps beyond that and that's where you start to think about it.

H P V being such a big global.

Infection, you know if you look at the you asked if you look at the B U 5 if you look at Japan, you got them all it's a very large market, but it's only a fraction.

Jay R. Luly: And that's where you start to think about HBV being such a big global infection. You know, if you look at the U.S., if you look at the EU5, if you look at Japan, you add them all up, it's a very large market, but it's only a fraction of the worldwide unmet need for treating and curing hepatitis B patients who are chronically infected. And so for global reach and scale. If you follow the dots, it's highly likely that we'll have a global commercialization partner.

The worldwide Uhm unmet need for treating and curing hepatitis P. Hepatitis b patients, who are chronically infected and so for global reach.

And scale.

There's if you follow the dots because it's highly likely that we'll have a a global commercialization partner.

Jay R. Luly: Would we retain the co-commercialization opportunity in certain territories? At least the option to do that? We had that option with two different drugs in our hepatitis C program with Abby, but we elected not to do co-commercialization. At the time we needed to elect to do that, we were, in one instance, we were a private company, and another instance, maybe even both times, might have been a private company. There's no way we could have even contemplated that.

Would we retain uhm co commercialization opportunity and certain territories, yes.

At least the option to do that we had that option with 2 different drugs and or hepatitis C program with Abby we elected not to do co commercialization at the time, we needed to elect to do that we were.

And 1 instance, where a private company and another instance of and maybe even both times it might've been a private country. There's no way, we could have even contemplated that and fast forward and thinking and a few years and in the future if.

Jay R. Luly: Fast forward a few years into the future, if we have an all oral triple, it could be a different set of circumstances for us, and we'll see where we are at that time. But I do believe we'll still, independent of that, we'll still want to have another partner to help us maximize this for patients worldwide.

We have on all world Triple.

And it could be a different set of circumstances for us.

And and we'll see where we are at that time, but I do believe we will still independent of that and we'll still want to have a another partner to help us.

And to maximize this to patients worldwide.

Matt: Okay, got it. Yeah, that's awesome, really helpful. Thank you. And then the last question we had was just on EDP-938. And so for the pediatrics and adult studies that you recently initiated, just curious what you're hoping to see in the data there, also, when we could expect to see data, and kind of how you're thinking about the market opportunities for each.

That helpful.

Okay got it yeah, that's awesome really helpful. Thank you and and the last customer and we had was just on E. D. P 3938, and so for the Pediatrics and adult studies that you recently initiated just curious what you're hoping to see and the date of their also when we could expect to see data and kind of how you're thinking about those.

The market opportunities for for each that would be great. Thank you.

Matt: That would be great. Thank you. Yeah.

Yep, well pieces, the biggest and I'll tell you that you know the pieces is a very large market.

Jay R. Luly: Yeah, well, PEDs is the biggest, I'll tell you that.

Jay R. Luly: You know, the PEDs are a very large market. Transplants are a very important market also. I mean, these folks who are immune compromised, if they get an RSV infection, it can just be catastrophic.

Transplants very important market also <unk> folks who are immune compromised and if they get and RSV infection and it can just be catastrophic.

And so it's a really important other patient population, but pizza pizza is definitely.

Jay R. Luly: And so it's a really important other patient population, but PEDs is definitely a larger population. Now, the transplant study we just got going at the end of last year, and the PED study we just got going in March. And also, I'll remind you too, in the PED study, the first part of it is really safety and PK, and then the second part of it is when we get into, you know, other aspects of the RSV infection.

And larger population now.

Transplants study, we just got on at the end of last year and the P. And study, we just got going and March.

And and.

And also I'll remind you too and and the Pizza study you know and the first part of it is is really safety and P. K.

And then the second part of it is when will get into you know other other aspects of our assume infection uhm, but so those are those are necessarily tracking behind.

Jay R. Luly: So those are necessarily tracking behind a study RSVP, which we already had ongoing and partially enrolled. So it's a bit early for us to give any sense of timing on those two studies, other than they're going to be further out. I think this upcoming season will be very telling for each of them. Allow us, you know, once we get this next season under our belts, I think we'll have a much better idea.

A study R. S V P, which we already had ongoing and partially enrolled so it's a bit early for us to give any sensitive timing on those 2 studies on there that they're gonna be you know further out I think this upcoming season will be very telling and each of them.

And loss and I once we get this next season under our belts I think will net weather and much better idea of where you stand.

Matt: Okay, I got it. That makes sense.

Okay got it that makes sense really helpful. Thanks again for taking the questions.

Zegabajala: Really helpful. Thanks again for taking the questions. You're welcome. Your next question will come from Zegabajala at Ross Capital Markets. Please proceed.

You're welcome.

Your next question will come from the second that genre with Roth capital markets. Please proceed.

Zegabajala: Hi, thanks for taking my question. Just had a quick one really about your COVID program; we're just wondering if you're considering any.

Hi, Thanks for taking my question just had a quick 1 valley and I got called they apparently and we're just wondering if you are considering any unique and treatment strategies in light of you know Ah. There you know cause I dragged day and approved by a vaccine and being able to find out. This is you know quite different names and.

Zegabajala: any unique treatment strategies in light of other COVID drugs being approved or vaccines being approved. I know this is quite different as a treatment, but we're just wondering because, you know, Regenarron did also get their drug approved as a prophylactic after exposure. So we're just wondering if you're thinking about anything unique in terms of when treatment will be delivered.

Treatment of it's just 1 game because you know if we get him on that I want to get that got approved and that's tough Alaska after exposure and somebody just wondering if you were thinking about anything unique and Kansas you know when treatment and will be delivered.

Jay R. Luly: Yeah, well, you know, treatment of any sort would be a major, major milestone. But I do believe you could also consider prophylactic in certain studies. So that's among the things that we're thinking about and chewing on. But straightforward treatment is clearly where the most urgent..., most urgent need is right now. So let's...

Yeah, well I I you know, there's no treatment of any store it would be a major a major milestone, but I I do believe you could also consider prophylaxis and certainly studying.

So that's among the things that we're thinking about and chewing on.

But straightforward treatment is is clearly.

Where where the most urgent must've.

And mustard and you won't need those right now so let's.

Assume that will do that and it's it's true there I mean, the the antibodies I think that are out there and played an important role.

Jay R. Luly: Assume that we'll do that, and it's true there. I think the antibodies that are out there played an important role, particularly early in the pandemic, and prior to vaccines, vaccines have kind of You know helped an enormous amount. It could obviously be helping even more, But I think ultimately the missing piece here and the piece that will be durable long term is going to be the small molecule antiviral molecule, direct acting antiviral, of which obviously 2,35 is. And there will be multiple generations for it to assume that people are going to be out there doing it.

Particularly early and the pandemic and and prior to vaccines vaccines have kind of.

You know help to an enormous amount and it could obviously be helping even more.

But I think ultimately the the missing piece here and a piece that will be durable longterm.

We're going to be the the small molecule.

Antiviral molecule direct acting antivirals.

Which obviously 235 is and there'll be multiple generations fair to assume that people are gonna be out there doing that and I mean, when we were going into Hep C.

Jay R. Luly: I mean, when we were going into FEC, you know, an ANTA wasn't the first protease inhibitor, but we were the best, you know. So, and even our first protease inhibitor, even though it was better than the prior ones that had been looked at, we came up with an even better one than that later on, which ultimately did become best in class with Le Capperever. So I think... 235 is a very strong entrant. We feel very good about it.

You know and and it wasn't the first.

Protease inhibitor, but.

And we were the best you know and so and even our first protease inhibitor, even though it was better and the prior 1 said had been looked at we we came up with and even better 1 than that and later on which ultimately did.

And become that's gonna classically calculus here, so I I think I'm too.

235 is a very strong and <unk>, we feel very good about it and.

And.

Jay R. Luly: We'll let the data speak.

And we'll we'll let the day to speak.

Zegabajala: Thank you, Shannon. Just a quick follow-up in terms of the dosing. What's the dose?

Zegabajala: What's the dose recommend, or what are you hoping to achieve with that?

Jay R. Luly: Well, we think we can, again, we always aim for QD dosing. You know, once daily is always best, and we pretty much always have hit that mark. Our pre-clinical studies suggest that that's likely to be the case here. I mean, we usually hit that mark in the clinic because we're very good at modeling that preclinically across multiple different species. And so we spent a lot of time, you know, sort of engineering that attribute as well.

Jay R. Luly: And I think people who know this landscape know that it's not necessarily a given that you can achieve that. So, again, we'll have to prove that in the clinic, but we feel very good about, you know, the kinetics that we've seen pre-clinically. And then beyond that, again, it's an acute infection as we would expect in normal people who have generally competent immune systems.

Jay R. Luly: We could do a short-term dosing, you know, probably, I mean, it wouldn't be unreasonable to assume it's something like a five-day dosing regimen, just like you do it. But, you know, we'll see. It's going to be short, relatively speaking, compared to, you know, some protracted, there's

Zegabajala: Thanks, Jay. I'm looking forward to hearing more about the program.

Operator: And at this time, there are no further questions. I would now like to turn the call back over to Jennifer Vieer for closing.

Jennifer Viera: For closing remarks.

Operator: Thank you everyone for joining us today. If you have any additional questions, please feel free to contact us by email or call us in the office. Thanks, and have a good night.

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

Operator: and so on, you know, and so much, you know, and so. Thank you, and so on. And so on, you know, and I'm going to be, and

[music].