Q1 2021 Atea Pharmaceuticals Inc Earnings Call

May 13, 2021

Operator 2: Good afternoon, ladies and gentlemen. Welcome to the Atea Pharmaceuticals Q1 2021 Financial Results Conference Call. At this time, all participants are in a listen-only mode. Following the formal remarks, we will open the call up for your questions. I would now like to turn the call over to Jonae Barnes, Senior Vice President of Investor Relations and Corporate Communications of Atea Pharmaceuticals. Please proceed.

Operator: Good afternoon, ladies, and gentlemen. Welcome to the Atea Pharmaceuticals Q1 2021 Financial Results Conference Call. At this time, all participants are in a listen-only mode. Following the formal remarks, we will open the call up for your questions. I would now like to turn the call over to Jonae Barnes, Senior Vice President of Investor Relations and Corporate Communications of Atea Pharmaceuticals. Please proceed.

Good afternoon, ladies and gentlemen, welcome to the <unk> Pharmaceuticals first quarter 2021 and financial results Conference call. At this time all participants are in a listen only mode. Following the formal remarks, we will open the call up for your questions I would now like to turn the call over to Joe and a bonds.

Operator: Ladies and gentlemen, welcome to the Aetia Pharmaceuticals first quarter 2021 financial results conference call. At this time, all participants are in a listen-only mode.

Operator: Following the formal remarks, we will open a call-up for your question. I would like an attorney callover to Joan A. Barnes, Senior Vice President of Investor Relations and Corporate Communications Communications of Atia Pharmaceuticals. Please, Thank you, Operator.

And your Vice President of Investor Relations and corporate Communications, all the T and Pharmaceuticals. Please proceed.

Jonae Barnes: Thank you, operator. Good afternoon, everyone, and welcome to Atea Pharmaceuticals' Q1 2021 Financial Results Conference Call. Earlier today, we issued a press release which outlines the topics we plan to discuss. You can access the press release as well as the accompanying slides that we'll be reviewing today on the call by going to the Investor Relations section, then the Events and Presentations area of our website at ir.ateapharma.com. With me today from Atea, our Founder, Chairman, and Chief Executive Officer, Jean-Pierre Sommadossi, Chief Development Officer, Janet Hammond, Chief Financial Officer and Executive Vice President of Legal, Andrea Corcoran. Chief Commercial Officer, John Vavricka, will also be available for the Q&A portion of today's call. On the call today, Jean-Pierre will provide a recap of our recent scientific publications and presentations for AT-527.

Jonae Barnes: Thank you, Operator. Good afternoon, everyone, and welcome to Atea Pharmaceuticals' Q1 2021 Financial Results Conference Call. Earlier today, we issued a press release which outlines the topics we plan to discuss. You can access the press release as well as the accompanying slides that we'll be reviewing today on the call by going to the Investor Relations section, then the Events and Presentations area of our website at ir.ateapharma.com. With me today from Atea, our Founder, Chairman, and Chief Executive Officer, Jean-Pierre Sommadossi, Chief Development Officer, Janet Hammond, Chief Financial Officer and Executive Vice President of Legal, Andrea Corcoran. Chief Commercial Officer, John Vavricka, will also be available for the Q&A portion of today's call. On the call today, Jean-Pierre will provide a recap of our recent scientific publications and presentations for AT-527.

Thank you operator, good afternoon, everyone and welcome to a Teva Pharmaceuticals first quarter 'twenty, One financial results conference call earlier today, we issued a press release, which outlines the topics. We plan to discuss you can access the press release as well as the accompanying slides that we'll be reviewing two day on the call by going to the investors.

Jonae R. Barnes: Good afternoon, everyone, and welcome to Atea Pharmaceutical's first quarter and 21 financial results conference call. Earlier today, we issued a press release that outlines the topics we plan to discuss. You can access the press release as well as the accompanying slide that we will be reviewing today on the call by going to the Investors Relations section, then the Invent and Presentations area of our website at ir.netiafarma.com. With me today from Atea are our founder, chairman, and chief executive officer, John Pierre Semedosi, Chief Development Officer, Janet Hammond, Chief Financial Officer, and Executive Vice President of Legal, Andrea Corcoran, and Chief Commercial Officer, John Vavrika, who will also be available for the Q&A portion of today's call.

Relations section and then the event.

And patients area of our website at IR Dot and pay your farm at Dot Com with me today from Italia, Our founder Chairman and Chief Executive Officer, John P or somebody does see Chief Development Officer, Janet Hammond, Chief Financial Officer, and Executive Vice President of legal Andrea work, Ryan Chief Commercial officer, John and beverage.

Philosophy available for the Q&A portion of today's call and the call today, John Peter will provide a recap of our recent scientific publications and presentations for a T. Five to seven Janet will review, our clinical progress for 85 to seven for the treatment of COVID-19, and 87 and five two for the treatment of dengue fever and Trey.

Jonae R. Barnes: On the call today, Jean-Pier will provide a recap of our recent scientific publications and presentations for AT 527, and Janet will review our clinical progress for AT 827 for the treatment of COVID-19 and AT752 for the treatment of dengue fever.

Jonae Barnes: Janet will review our clinical progress for AT-527 for the treatment of COVID-19 and AT-752 for the treatment of dengue fever. Andrea will provide a financial update, and Jean-Pierre will review the upcoming milestones. Before we begin the call, I'd like to remind you that today's discussion will contain forward-looking statements that involve risks and uncertainties, as mentioned on slide 2. These risks and uncertainties are outlined in today's press release and in the company's recent filings with the Securities and Exchange Commission, which we encourage you to read. Our actual results may differ materially from what is discussed on today's call. With that, I'll now turn the call over to Jean-Pierre.

Jonae Barnes: Janet will review our clinical progress for AT-527 for the treatment of COVID-19 and AT-752 for the treatment of dengue fever. Andrea will provide a financial update, and Jean-Pierre will review the upcoming milestones. Before we begin the call, I'd like to remind you that today's discussion will contain forward-looking statements that involve risks and uncertainties, as mentioned on slide two. These risks and uncertainties are outlined in today's press release and in the company's recent filings with the Securities and Exchange Commission, which we encourage you to read. Our actual results may differ materially from what is discussed on today's call. With that, I'll now turn the call over to Jean-Pierre.

Jonae R. Barnes: Andrea will provide a financial update, and John Pierre will review the upcoming milestone. Before we begin the call, I'd like to remind you that today's discussion will contain forward-looking statements that involve risk and uncertainties, as mentioned on slide 2. These risks and uncertainties are outlined in today's press release and in recent filings with the Securities and Exchange Commission, which we encourage you to read. Our actual results may differ materially from what is discussed on today's call.

And I will provide a financial update and John Peter will review the upcoming milestones before we begin the call I'd like to remind you that today's discussion will contain forward looking statements that involve risks and uncertainties as mentioned on slide two these risks and uncertainties are outlined in today's press release and in the company's recent filings with the Securities and Exchange Commission.

Which we urge you to read our actual results may differ materially from what is discussed on today's call with that I'll now turn the call over to John here.

John Boyle: With that, I'll now turn the call over to John Pierre. Thank you, Jone. Good afternoon, everyone.

John Boyle: Thank you, Jone. Good afternoon, everyone, and thank you for joining us today.

Jean-Pierre Sommadossi: Thank you, Jonae. Good afternoon, everyone, and thank you for joining us today. We continue to make meaningful progress of our mission to discover and develop antiviral drugs for the treatment and prophylaxis of severe viral diseases. Our purine nucleotide prodrugs have pharmacological properties that are uniquely suited for the treatment and prevention of these viral diseases. Our drug candidates are designed to target viral RNA polymerase, a highly conserved enzyme critical to the life cycle replication of these viruses. We believe our platform offers many advantages, including potent and selective antiviral activity, convenience of oral administration, and scalable manufacturing. All essential when targeting millions of patients worldwide. As we reported on our last conference call, we have been very active so far this year in publishing and presenting preclinical and clinical results for AT-527.

Good afternoon, everyone and thank you for joining us today.

John Boyle: We continue to make meaningful progress in our mission to discover and develop antiviral drugs for the treatment and prevention of severe viral diseases. Our purin nucleotide prodriads have pharmacological properties that are uniquely suited for the treatment and prevention of Israel diseases. Our jury candidates are designed to target viral polymerase, a highly conserved enzyme critical to the life cycle replication of these viruses. We believe our platform offers many advantages, including potent and selective antiviral activity, convenience of overall administration, and scalable manufacturing, all essential when targeting millions of patients worldwide.

We continue to make meaningful progress of our mission to discover and develop antiviral drugs for the treatment and prophylaxis of severe viral diseases.

Oh appealing nucleoside pro drugs.

Coloccia Coke properties that are uniquely suited for the treatment and prevention of these retinal diseases. Our drug candidates are designed to target volume polymerize and they.

Right.

A highly conserved enzyme critical to the lifecycle and reputation of these devices.

We believe our platform offers many advantages and clothing potent and selective and see them all activity convenience of all line of administration and scalable manufacturing all of this action and central and targeting and millions of patients worldwide.

John Boyle: As we reported on our last conference call, we have been very active so far this year in publishing and presenting preclinical and clinical results for 85-7. A recap of our scientific communications is on slide 3, and includes publishing a manuscript highlighting the potent virtual activity of 85-27 against SARS-Corp 2 in antimicrobial agents and chemotherapy. We presented favorable phase-1 results in March at the conference on retroviruses and opportunistic infections, or quoit. These results validate the modeling from our preclinical animal models, which predict the drug lung levels should consistently be above the EC-10 level of 0.5 micro-mola.

As we reported on our last conference call, we have been very active so far this year and.

Michigan, and presenting preclinical and clinical results for <unk> five to seven.

Jean-Pierre Sommadossi: A recap of our scientific communications is on slide 3 and include publishing a manuscript highlighting potent in vitro activity of AT-527 against SARS-CoV-2 in Antimicrobial Agents and Chemotherapy. We presented favorable phase 1 results in March at the Conference on Retroviruses and Opportunistic Infections, or CROI. These results validate the modeling from our preclinical animal models, which predict the drug lung levels should consistently be above the EC90 level of 0.5μM. Since the respiratory tract is the initiation site of the SARS-CoV-2 replication. This data demonstrate the potential for AT-527 to achieve meaningful drug levels in the lungs. We were also invited to present supportive data on AT-527 as a treatment for COVID-19 at the International Conference on Antiviral Research or ICAR. The overview included phase 1 results as well as preclinical data and the underlying mechanistic rationale supporting.

Jean-Pierre Sommadossi: A recap of our scientific communications is on slide three and include publishing a manuscript highlighting potent in vitro activity of AT-527 against SARS-CoV-2 in Antimicrobial Agents and Chemotherapy. We presented favorable phase I results in March at the Conference on Retroviruses and Opportunistic Infections, or CROI. These results validate the modeling from our preclinical animal models, which predict the drug lung levels should consistently be above the EC90 level of 0.5μM. Since the respiratory tract is the initiation site of the SARS-CoV-2 replication. This data demonstrate the potential for AT-527 to achieve meaningful drug levels in the lungs. We were also invited to present supportive data on AT-527 as a treatment for COVID-19 at the International Conference on Antiviral Research or ICAR. The overview included phase I results as well as preclinical data and the underlying mechanistic rationale supporting.

Recap scientific communications who's on slides, three and and crude publishing and minus script, highlighting potent in vitro activity and fraud.

85 to seven.

Sars Cov, two and then see microbial agents and chemotherapy, we presented favorable phase one results in March and the conference on retroviruses and opportunistic infections and quote.

These results validate the modeling from a preclinical animal models, which predicts the drug and lung levels should consistently be above it.

And you see 90 level of 0.5 micro model.

John Boyle: Since the respiratory track is the initiation site of the SARS-Cov-2 replication, these data demonstrate the potential for AT5-7 to achieve meaningful drug levels in the law. We were also invited to present supportive data on 85-7 as a treatment for COVID-19 at the International Conference on Antiviral Research, or ICAR. The overview included phase-1 results, as well as pre-clinical data and the underlying mechanistic rationale supporting the, In addition, We have worked very diligently to elucidate the dual-machry faction of 85-7 and the multi-modal and unique interactions with 1890-10, the active trifosate metabolite of 80-5-2-7 against SOSCOV RNA polymer, manuscript of this important data is currently in preprint on bio archives and has been submitted for peer review.

Since the respiratory tract is D initiation site or the <unk>.

<unk> got two application these day that demonstrate the potential for five to seven to achieve meaningful drug levels in the lungs.

And also we invited to present supportive data and the 85 to seven as a treatment for COVID-19 at the International Conference and antiviral research of eyeball, the overview, including phase, one and resolved as well as preclinical data and the underlying mechanistic rationale supporting.

Yeah.

Jean-Pierre Sommadossi: In addition, we have worked very, very diligently to elucidate the dual mechanism of action of AT-527 and the multimodal and unique interactions with AT-9010, the active triphosphate metabolite of AT-527 against SARS-CoV-2 RNA polymerase. A manuscript of this important data is currently in preprint on bioRxiv and has been submitted for peer review. This growing body of preclinical and clinical evidence in support of our antiviral platform is compelling and encourages us to accelerate and expand our development pipeline in a variety of difficult-to-treat viral diseases. Let me now turn the call over to Janet, who will review our clinical development programs. Janet.

In addition.

We have worked very very diligently to elucidate the dual mechanism of faction of 55 to seven and the mall model and and unique interactions with 18 90 10.

Active triphosphate metabolites of 85 to seven against Sars cov, either they pretty mice and minus script. This important data is good the appropriate on bio archive and that's been submitted for peer review.

John Boyle: This growing body of preclinical and clinical evidence in support of our antiviral platform is compelling and encourages us to accelerate and expand our developing pipeline for the very difficult to treat viral diseases. Let me now turn the call over to Janet, who will review our clinical development programs.

This growing body of preclinical and clinical evidence in support of our antiviral platform is compelling and encourages us to accelerate and expand our development pipeline and the variety of difficult to treat viral diseases.

Let me now turn the call over to Janice who.

And we view our clinical development programs Janet.

Janet M. J. Hammond: Thank you, Jean-Pierre. On slide five, I'll begin with an overview of the ways 8527, our lead product candidate, may address the challenges that currently exist with the treatment and prevention of COVID-19. We believe that oral direct acting antivowels or DAAs can play an essential role in the treatment of COVID-19 with their ability to rapidly inhibit viral replication in the early phase of infections and potentially reduced disease progression, which for COVID-19 would lead to a meaningful impact on global health.

Janet Hammond: Thank you, Jean-Pierre. On slide 5, I'll begin with an overview of the ways AT-527, our lead product candidate, may address the challenges that currently exist with the treatment and prevention of COVID-19. We believe that oral direct-acting antivirals or DAAs can play an essential role in the treatment of COVID-19, with their ability to rapidly inhibit viral replication in the early phase of infection and potentially reduce disease progression, which for COVID-19 would lead to a meaningful impact on global health. We believe that based on AT-527's profile, it has the potential to accelerate time to recovery, prevent or shorten hospitalization, and reduce medically attended visits. It also has the potential to reduce the transmission of virus and hopefully can impact long-term COVID sequelae. DAAs may be used in pre- and post-exposure prophylaxis.

Thank you jump here on slide five I'll begin with an overview of the way, it's 85 to seven and lead product candidate may address the challenges that currently exist to treat mentioned prevention of COVID-19.

We believe that our old direct acting antivirals or D. A a container and essential role and the treatment of COVID-19 with ever been to teach erratic inhibit viral replication and the anti faces infection and.

And potentially reduce disease progression, which for COVID-19 would lead to a meaningful impact on global health.

Janet M. J. Hammond: We believe that based on 85-27's profile, it has the potential to accelerate time to recovery, prevent or shorten hospitalization, and reduce Medicare-accompanying visits. It also has the potential to reduce the transmission of the virus, and hopefully, it can impact long-term COVID sequelae. BAAs may be used in pre-anthropostics surgery prophylax. These are all key objectives that we aim to evaluate in the clinical program for 85-27, that we are conducting globally with our partner Roche.

We believe that based on 85 Stephens profile. It has the potential to accelerate time to recovery per well.

Or shorten hospitalization and reduce Medicare tended visits.

It also has the potential to reduce the transmission of virus and hopefully can impact long term COVID-19 zucchini.

D J as maybe your reach and pre and post exposure prophylaxis.

Janet Hammond: These are all key objectives that we aim to evaluate in the clinical program for AT-527 that we are conducting globally with our partner, Roche. We view the use of a DAA as complementary to COVID vaccines. This is a similar treatment paradigm to influenza. We believe that a multipronged approach, including both prevention and treatment, will be essential for the challenges that we will continue to face with this virus. Moving to slide 6. As summarized, we expect it to be an eventful year for AT-527, as highlighted by the multiple global clinical trials we plan to conduct with our partner, Roche. Throughout 2021 and beyond, we will be delivering a series of data readouts that will form our roadmap to a near-term NDA submission and product launch.

These are all key objectives that we aim to evaluate and the clinical program for 85 to seven and that's without conduction jeopardy with our partner Roche.

Janet M. J. Hammond: We view the use of a DAA as complementary to COVID vaccines because this is a similar treatment paradigm to influenza. We believe that a multi-pronged approach, including both prevention and treatments, will be essential for the challenges that we will continue to face with this virus. Moving to slide six, as summarized, we expect it to be an eventful year for 85-27, as highlighted by the multiple global clinical trials we plan to conduct with our partner Roche. Throughout 2021 and beyond, we will be delivering a series of data readouts that will form our roadmap to a near-term NDA submission and product launch.

We view the use of a day as complementary to COVID-19 vaccines. This.

And is a similar treatment paradigm change and.

We believe that a multi pronged approach intrusion prevention and treatments will be essential for the challenges that we will continue to face with the sauce.

Moving to slide six and summarized we expect it to be an eventful year for 85 to seven is highlighted by the multiple cable clinical trials, we plan to conduct without passing and bearish.

Throughout 2021 and beyond we will be delivering a series of data readouts that will form a road map to and yet NDA submission and product launch.

Janet M. J. Hammond: We expect interim virology data from the Phase 2 program later this quarter, and we expect results from the Global Phase 3 trial in the second half of the year. In addition, we anticipate initiating a prophylaxis study. Moving to slide 7, in April, we were excited to announce the initiation of the Phase 3 Morning Sky trial, a global, multi-center trial evaluating AT527 in mild or moderate COVID-19 patients in an outpatient setting. This trial is being conducted with our partner Roche and is currently enrolling Rohing patients outside of the United States.

Janet Hammond: We expect interim virology data from the phase 2 program later this quarter, and we expect results from the global phase 3 trial in H2. In addition, we anticipate initiating a prophylaxis study. Moving to slide 7. In April, we were excited to announce the initiation of the phase 3 MORNINGSKY trial, a global multicenter trial evaluating AT-527 in mild or moderate COVID-19 patients in an outpatient setting. This trial is being conducted with our partner, Roche, and is currently enrolling patients outside of the United States. We anticipate it will enroll approximately 1,400 adults and adolescents with mild to moderate COVID-19. Patients with or without risk factors will be randomized within 5 days of symptom onset. At the time of enrollment, patients must be stable and not require hospitalization.

We expect interim data from the Phase two program later this quarter and we expect results from the global Phase III trial, and the second half Avia and.

In addition, we anticipate initiating a prophylaxis study.

Moving to slide seven in April we were excited to announce the initiation of the phase three morning Sky trial, a global multi center trial evaluating 85 to seven and mild or moderate COVID-19 patients and in the outpatient setting.

This trial is being conducted with our partner Roche and is currently and voting patients outside of the United States.

Janet M. J. Hammond: We anticipate it will enroll approximately 1,400 adults and adolescents with mild to moderate COVID-19. Patients with or without risk factors will be randomized within five days of symptom onset. At the time of enrollment, patients must be stable and not require hospitalization.

We anticipate it will enroll approximately 1400 adults and adolescents with mild to moderate COVID-19.

Patients with or without risk factors, who will be randomized with and five days of symptom onset.

At the time of enrollment patient supposed to be stable and Doctor class utilization.

Janet M. J. Hammond: The primary endpoint evaluating the efficacy of 8527 compared with placebo will measure the time to alleviation or improvement of COVID-19 symptoms. Other efficacy endpoints will include the number of patients requiring medically attended visits or hospitalization for COVID-19. Additionally, among other secondary and exploratory endpoints, the study will also identify and or evaluate biomarkers that are predictive of an antiviral response to 8527. Moving to slide eight.

Janet Hammond: The primary endpoint evaluating the efficacy of AT-527 compared with placebo will measure the time to alleviation or improvement of COVID-19 symptoms. Other efficacy endpoints will include the number of patients requiring medically attended visits or hospitalization for COVID-19. Additionally, among other secondary and exploratory endpoints, the study will also identify and/or evaluate biomarkers that are predictive of an antiviral response to AT-527. Moving to slide 8. In tandem with the phase 3 program, we are continuing to make progress with the ongoing phase 2 study in hospitalized patients. We expect to report interim virology data on a meaningful number of patients from this study later this quarter.

The primary endpoint evaluating the efficacy of 85 to seven compared with placebo well measure the time to alleviation or improve and just COVID-19 symptoms.

And the efficacy endpoints will include the number of patients requiring medically attended visits hospitalization for COVID-19.

Additionally, among other secondary and exploratory endpoints. The study will also identify and evaluate biomarkers that are predictive of and antiviral response to 85 to seven.

Moving to slide eight in tandem with the phase III program, we are continuing to make progress with the ongoing phase two study in hospitalized patients.

Janet M. J. Hammond: In tandem with the Phase 3 program, we are continuing to make progress with the ongoing Phase 2 study in hospitalized patients. We expect to report interim virology data on a meaningful number of patients from this study later this quarter. I would like to highlight some of the features of our study in the hospitalized setting, which is a placebo-controlled study with strict inclusion criteria, such as requiring patients to have been hospitalized within five days or less of symptom onset. In addition, our study includes only patients with moderate COVID-19 who require no or minimal respiratory support.

We expect to report interim data on a meaningful number of patients from the study later this quarter.

Janet Hammond: I would like to highlight some of the features of our study in the hospitalized setting, which is a placebo-controlled study with strict inclusion criteria, such as requiring patients to have been hospitalized, within 5 days or less of symptom onset. In addition, our study includes only patients with moderate COVID-19 who require no or minimal respiratory support. You will recall that this is a phase 2 proof of concept study and is not statistically powered. We consider this phase 2 trial to be a study where we will be able to obtain proof of concept for antiviral efficacy and supportive data for dosage, and most importantly, confirm the safety profile of the drug, which was the main reason for conducting this study in a monitored hospital setting. Moving to slide 9.

I would like to highlight some of the features of Voc study in Huston and hospitalized setting which is a placebo controlled study with strict inclusion criteria.

Requiring patients who have been hospitalized.

With within five days or less of symptom onset.

In addition, our study and choose only patients with moderate COVID-19, who required no or minimal respiratory support.

You will recall that this is a phase two proof of concept study and is not statistically part.

Janet M. J. Hammond: You will recall that this is a phase two proof-of-concept study and is not statistically powered. We consider this phase two trial to be a study where we will be able to obtain proof-of-concept for antiviral efficacy and supportive data for dosage, and, most importantly, confirm the safety profile of the drug, which was the main reason for conducting this study in a monitored hospital setting. Moving to slide nine, the phase two outpatient trial is evaluating safety, PK, and PD, and antiviral activity of 8527 when compared with placebo.

We continue this phase two trial to be a study, where we will be able to obtain proof of concept for antiviral efficacy and supportive data for dosage and most importantly confirmed the safety profile of the drug.

It was the main reason for conducting the study and are monitored hospital setting.

Moving to slide nine.

Janet Hammond: The phase 2 outpatient trial is evaluating safety, PK, and PD, and antiviral activity of AT-527 compared with placebo. The continuing supportive data for safety and tolerability is important in the outpatient setting. This is the same setting for the phase 3 trial and is the target population where we anticipate the majority of the drug will be used if approved. Once again, this is a phase 2 proof of concept study and is not statistically powered. The footprint of this trial is expanding globally, which should alleviate enrollment challenges initially encountered with the UK sites. Let's now turn to AT-752, our program for the treatment and prophylaxis of dengue fever on slide 11. In March, we initiated a randomized, double-blind, placebo-controlled, single- and multiple-ascending-dose phase 1a study to evaluate the safety, tolerability, and pharmacokinetics of AT-752 in healthy subjects.

The phase two outpatient trial is evaluating safety PK and PD and antiviral activity of 85 to seven compared with placebo.

And the continuing support of day to the safety and Tolerability is important and the outpatient setting.

This is the same searching for the phase III trial and is the target population, where we anticipate the majority of the drug will be used if approved.

Janet M. J. Hammond: The continuing supportive data for safety and tolerability are important in the outpatient setting. This is the same setting for the phase three trial and is the target population where we anticipate the majority of the drug will be used if approved. Once again, this is a phase two proof of concept study and is not statistically powered. The footprint of this trial is expanding globally, which should alleviate enrollment challenges initially encountered with the UK side.

And once again this is a phase two proof of concept study and is not statistically powered.

The footprint of this trial is expanding globally, which should alleviate and Goldman challenges initially and counted with the U K sites.

Let's now turn to 87 and five to our program for the treatment and prophylaxis of dengue fever on slides 11.

In March we initiated a randomized double blind placebo controlled single and multiple ascending dose phase one day studies to evaluate the safety Tolerability and pharmacokinetics of 87, and five two and healthy subjects.

Janet M. J. Hammond: Let's now turn to AG752, our program for the treatment and prophylaxis of dengue fever. In March, we initiated a randomized, double-blind, placebo-controlled, single and multiple ascending dose phase 1A study to evaluate the safety, tolerability, and pharmacokinetics of H.E.752 and healthy substances. Subject Enrollment continues to involve patients. The Phase 1A study is anticipated to enroll up to 60 patients. The objective of this study is to establish the safety and tolerability of AG752 and also to support dose selection for future studies of 8752 as a treatment and prophylaxis of dengue fever.

Janet Hammond: Subject enrollment continues to advance. The Phase 1a study is anticipated to enroll up to 60 patients. The objective of the study is to establish the safety and tolerability of AT-752 and also to support dose selection for future studies of AT-752 as a treatment in prophylaxis of dengue fever. We expect to report data from the Phase 1 study in H2. With that overview, I'll now turn the call over to Andrea for a review of the financials.

Subject enrollment continues to advance.

The phase one studies anticipated rollout just enroll up to 60 patients. The objective of this study is to establish the safety and Tolerability of <unk> 87, and five two and also to support dose selection for future studies should H hitting five two and the treatment and prophylaxis of dengue fever.

We expect to report data from the Phase one study and the second half of yeah.

With that change of view I'll now turn the call over to Andrea for a review of the financials.

Andrea Corcoran: Thank you, Janet. As Joni mentioned in her introductory remarks, earlier this afternoon, we issued a press release containing our financial results for Q1 2021. The statement of operations and balance sheet as of 31 March 2021 are on slides 13 and 14. For Q1 2021, the increase in research and development expenses in comparison to Q1 2020 was principally driven by an increase in external clinical development and manufacturing expenses incurred primarily in conjunction with the advancement of AT-527 for the treatment of COVID-19, and to a lesser extent, AT-752, which, as you've heard, is being developed for dengue fever. These expenses included our share of costs incurred by Roche and increases in internal spend, primarily due to an increase in personnel-related expenses.

Thank you Janet.

Mr. Nate mentioned in her introductory remarks earlier. This afternoon, we issued a press release containing our financial results for the first quarter of 2021.

The statement of operations and balance sheet as of March 31, 2021 are on slides 13 and 14.

Andrea J. Corcoran: We expect to report data from the Seisman study in the second half of the year. With that overview, I'll now turn the call over to Andrea for a review of the financials. Thank you, Janet.

For the first quarter 2021 and the increase in research and development expenses and comparison to the first quarter of 2020 was principally driven by an increase and external clinical development and manufacturing expenses incurred primarily in conjunction with the advancement of 85 to seven for the treatment of COVID-19.

Andrea J. Corcoran: As Jonae mentioned in her introductory remarks, earlier this afternoon, we issued a press release containing our financial results for the first quarter of 2021. The Statement of Operations and Balance Sheet as of March 31, 2021, are on slides 13 and 14. For the first quarter of 2021, the increase in research and development expenses in comparison to the first quarter of 2020 was principally driven by an increase in external clinical development and manufacturing expenses incurred primarily in conjunction with the advancement of AT527 for the treatment of COVID-19 and, to a lesser extent, AT752, which, as you've heard, is being developed for dengue fever.

And to a lesser extent 87, two which as you've heard is being developed for dengue fever.

These expenses included our share of cost incurred by Roche and increases and internal spend primarily due to an increase and personnel related expenses.

Andrea Corcoran: The increase in general and administrative expenses was primarily due to expansion of our organization and consists principally in an increase in payroll and personnel-related expenses. I am pleased to report that we ended Q1 with an exceptionally strong balance sheet to support our clinical development programs. As of the end of Q1, cash and cash equivalents were $833.8 million. We anticipate our current cash run rate will take us through 2023 to advance each of our pipeline programs. Apart from our financial results, I would also like to note that the IPO lock-up recently expired and previously restricted shares became available for trading beginning on 28 April. As expected, we experienced an increase in trading volume around this event, which continues. I'll now turn the call back over to Jean-Pierre for closing remarks.

The increase in general and administrative expenses was primarily due to expansion of our organization and consists principally and an increase in payroll and personnel related expenses.

I am pleased to report that we ended the first quarter with an exceptionally strong balance sheet to support our clinical development programs.

As of the end of the first quarter cash and cash equivalents were $833.8 million.

Andrea J. Corcoran: These expenses included our share of costs incurred by Roche and increases in internal spend primarily due to an increase in personnel-related expenses. The increase in general and administrative expenses was primarily due to the expansion of our organization and consisted principally in an increase in payroll and personnel-related expenses. I am pleased to report that we ended the first quarter with an exceptionally strong balance sheet to support our clinical development program. As of the end of the first quarter, cash and cash equivalents were $833.3 million.

We anticipate our current cash runway will take us through 2020 three to advance each of our pipeline programs.

Apart from our financial results and we'd also like to note that the IPO lockup recently expired and previously restricted shares became available for trading beginning on April 28 Asics.

As expected, we experienced an increase and trading volume around this event, which continues.

I'll now turn the call back over to Sean here for closing remarks.

Jean-Pierre Sommadossi: Thank you, Andrea. 2021 is off to a strong start, highlighted by the initiation of the global phase 3 MORNINGSKY trial of AT-527 in mild to moderate COVID-19 patients in the outpatient setting. This was a significant milestone and represents a major advancement toward our goal of providing an easily administered and widely available oral antiviral to help in the fight against this global pandemic. We look forward to sharing interim biology data from the phase 2 program for AT-527 later this quarter and reporting data from our phase 1a study of AT-752, which is being developed for the treatment and prophylaxis of dengue fever in H2 2021. We continue to make progress with the other drug candidates in our antiviral pipeline and explore and expect to report progress on these programs later this year.

Thank you Andrea.

2020, one is off to a strong start highlighted by the initiation of the global phase III and long and Sky and trial.

Five to seven and mild to moderate and COVID-19 patients and the outpatient setting.

Andrea J. Corcoran: We anticipate our current cash run right will take us through 2023 to advance each of our pipeline programs. Apart from our financial results, I would also like to note that the IPO lockup recently expired, and previously restricted shares became available for trading beginning on April 28. As expected, we experienced an increase in trading volume around this event, which continues. I'll now turn the call back over to Jantir for closing remarks. Thank you.

This was a significant milestone and represents a major advancement towards and I won't go providing and easily administered and widely available on tmall to help and the fight against this global pandemic.

Look forward to sharing and to vinyl which is data from the phase II program for <unk> five to seven later this quarter and reporting data from our phase one and a study of 87 and five two which is being devil out for the treatment and prophylaxis of dengue fever, and the second half of 2020 one.

We continue to make progress with the <unk>.

And to a drug candidates.

John Boyle: Thank you, Andrea. 2021 is off to a strong start, highlighted by the initiation of the Global Phase 3 in Morning Sky Trial of 85 to 7 in mild to moderate COVID-19 patients in the outpatient setting. This was a significant milestone and represents a major advancement toward our goal of providing an easily administered and widely available all-anti-vowel vaccine to help in the fight against this global pandemic. We look forward to sharing interim biology data from the Phase 2 program for AT527 later this quarter and reporting data from our Phase 1A study of 8752, which is being developed for the treatment and prophylaxis of dengue fever in the second half of 2021

And while antiviral pipeline and export and expect to report progress on this program later this year.

Jean-Pierre Sommadossi: We remain steadfast in our mission to advance these important programs to the benefit of patients worldwide. We have the right people, the right programs, and the right partner to bring these potentially life-saving drugs to market. Importantly, we have the financial resources to support this mission. With that, operator, we will now open the call up to questions.

We remain steadfast in our mission to advance these important programs to the benefit of patients who worthwhile and we have the right people the right programs and the right partner to bring this potentially life saving drugs to market and importantly, we have the financial resources to support the submission.

With that operator, we'd.

We will now open the call up to questions.

Operator 2: Thank you, sir. Ladies and gentlemen, if you have a question at this time, please press the star, then the number one key on your touchtone telephone. If your question has been answered or you wish to remove yourself from the queue, please press the pound key. Your first question is from Eric Joseph from J.P. Morgan. Your line is open.

Operator: Thank you, sir. Ladies, and gentlemen, if you have a question at this time, please press the star, then the number one key on your touchtone telephone. If your question has been answered or you wish to remove yourself from the queue, please press the pound key. Your first question is from Eric Joseph from JPMorgan. Your line is open.

Thank you, Sir ladies and gentlemen, if you have a question at this time. Please press. The Star then the number one key on your Touchtone telephone. If your question has been answered or you wish to remove yourself from the queue. Please press the pound key.

Your first question is from Eric Joseph from Jpmorgan. Your line is open.

John Boyle: We continue to make progress with the other drug candidates in our anti-vow pipeline and expect to report progress on these programs later this year. We remain steadfast in our mission to advance these important programs to the benefit of patients worldwide. We have the right people, the right programs, and the right partners to bring these potentially life-saving drugs to market. And, importantly, we have the financial resources to support this mission. With that, operator, we will now open the call up to crash.

Eric Joseph: Hi. Thank you. Good evening. Thanks for taking my questions. Just hoping you could provide a bit of an update on enrollment progress in the Phase 2 trials. You're reiterating timelines for data update later this quarter. Should we anticipate a full enrollment of both the outpatient and hospitalized studies? Or should we expect sort of a partial number? And if it's the latter, maybe you can kind of guide expectations there and then I have a follow-up.

Hi, Thank you good evening and taking my questions.

Just hoping you could provide a bit of and update on enrollment progress and the.

Our phase two trials youre reiterating and timelines for data update later this quarter are you and should we anticipate a flow.

Yeah.

Enrollment of both the outpatient and.

Hospitalized studies or should we expect sort of a partial number and if it's the latter.

Maybe you can kind of guide expectations, there and then I have a follow up.

Jean-Pierre Sommadossi: Jan?

Jean-Pierre Sommadossi: Janet?

John.

Yes.

Janet Hammond: Thank you for the question. We're not anticipating that either study will have completed enrollment. We will, I believe, have a substantial number of patients that we will be able to report data on, and we're hoping that this will be able to provide a trend in our understanding of the viral kinetics associated with the drug in our hospitalized study. As I mentioned earlier, our patient study has considerably expanded its footprint and sites are coming on stream really all the time now. We anticipate that the enrollment will move forward pretty expeditiously. Actually the design of that study allows for us to explore different doses.

So thank you for the question we will.

Dissipating that either study would have completion of enrollment.

Operator: Thank you. Ladies and gentlemen, if you have a question at, please press the star, then the number one key on your Touchstone, Towers, when your question has been answered or you wish to remove yourself from the Q. Your first question is from Eric Joseph, from JP.

And we will I believe have a substantial <unk>.

Number of patients that we will be able to report data on and we were hoping that this will be able to provide trend and our understanding of the viral kinetics and associated with the drug and all hospitalized study as I mentioned earlier the.

Eric William Joseph: Your line is open. Hi, thank you. Good evening. Thanks for taking the questions. Just hoping you could provide a bit of an update on enrollment progress in phase two.

Ah patient study.

<unk> expanded its footprint and sites are coming on stream and.

Eric William Joseph: Trials, you're reiterating timelines for data updates later this quarter. Are you in, or should we anticipate a full

Really all the time now so we anticipate that the enrollment will and move forward pretty expeditiously and actually the design of that study.

Janet M. J. Hammond: anticipate a full enrollment of both the outpatient and hospitalized studies, or should a sort of partial number be expected, and if it's the latter, maybe you can kind of guide expectations there, and then I have a follow-up. So thank you for the question.

Allows for us to it.

Different doses. So they will that will be cohorts of patients that we will look at and.

Janet Hammond: There will be cohorts of patients that we will look at and we will have data, we believe from Roche on an initial cohort from that first dosing cohort to report by the end of Q2.

We will have data we believe from Roche on a on an initial cohort from that from that first dosing cohort to reported by the end of the two.

Janet M. J. Hammond: We're not anticipating that either study will have completed enrollment. We will, I believe, have a substantial number of patients that we will be able to report data on, and we're hoping that this will be able to provide a trend in our understanding of the viral kinetics associated with the drug in our hospitalized study. As I mentioned earlier, the outpatient study has considerably expanded its footprint, and sites are coming on stream really all the time now, so we anticipate that enrollment will move forward pretty expeditiously.

Second quarter.

Eric Joseph: Okay, that's very helpful. As it relates to the Phase 3 MORNINGSKY trial, can you talk about the geographic distribution of participating sites currently, and what gating factors are remaining to facilitate approvals or the initiation of sites in the US? Is there a minimum or do you anticipate a minimum number of patient participation in the US to facilitate registration there? Thank you.

Okay, that's very helpful and.

And as it relates to the phase III bordering states Ralph.

Talk about the.

Uh huh.

Geographic distribution of our participating sites currently and.

And what gating factors are.

And the remaining to facilitate approvals.

Yes, the initiation of sites and the U S.

And is there a minimum.

Or do you anticipate a minimum of minimum number.

Ah patient participation and the U S and facilitate penetration.

Thank you.

Janet Hammond: I'm sorry, Eric, I didn't get. Do I anticipate what? I didn't hear what you said.

I'm, sorry, Eric and I didn't get do I anticipate what I didn't hear what you said.

Eric Joseph: A minimum number of US patient participation to facilitate registration with FDA.

A minimum number.

U S patient participation to facilitate registration with the FDA.

So the the.

Janet M. J. Hammond: And actually, the design of that study allows for us to explore different doses. So there will be cohorts of patients that we will look at, and we will have data, we believe, from Roche on an initial cohort from that first dosing cohort to report by the end of the second course. Okay, that's very helpful. And as it relates to

Janet Hammond: The study is open in countries in Europe at the moment, and we are seeing other countries opening up around the world as the CTA gets approved, including Japan, and there are more countries still to come. We are making good progress with the FDA, and we anticipate that we will be able to enroll patients in the US in the foreseeable future once we've resolved the issues around that with them. We anticipate that there should be representation of the US in the study. Yes.

The study is open and countries in Europe and their image and we are seeing.

Other countries are opening up around the world with the Cta gets approved and income.

In Japan and.

And more countries still to come we are making good progress with the FDA and we anticipate that and we will be able to in low and patients and the U S and the foreseeable future once we've resolved.

Janet M. J. Hammond: Day 3, Morning Sky Trout, can you talk about the geography?

Janet M. J. Hammond: the geographic distribution of participating sites currently, and what gating factors are remaining to facilitate approvals or the initiation of sites in the U.S. Is there a minimum, or do you anticipate a minimum number of patients, patient participation in the U.S. to facilitate registration there? Thank you. Sorry, Eric, I didn't hear what you said.

The issues around that way with them. So we anticipate that that should be a representation of the U S and study yes.

Eric Joseph: Okay. Thanks for taking the questions. I'll hop back in queue.

Okay. Thanks for taking my questions and I'll hop back in queue.

Operator 2: Your next question is from Matthew Harrison for Morgan Stanley. Your line is open.

Operator: Your next question is from Matthew Harrison for Morgan Stanley. Your line is open.

Your next question is from Matthew Harrison from Morgan Stanley. Your line is open.

Matthew Harrison: Great. Good afternoon. Thanks for taking the questions. I guess two for me. First, on the first dosing cohort, assuming that's what we get in terms of interim data, can you just maybe help us think about what you know from drug levels and exposure about what you think is reasonable to expect in terms of viral load decline in those patients? I guess separately, given some of the enrollment issues that you faced with these initial studies, can you just talk about your confidence around being able to enroll the phase 3 quickly? Thanks.

Great. Good afternoon, thanks for taking the questions I guess two for me first.

On the first dosing cohort and assuming that's what we get in terms of interim data can you just.

Maybe help us think about what you know from drug levels and exposure about what you think is reasonable to expect in terms of viral load decline and in those patients and then I.

Janet M. J. Hammond: A minimum number of US patient participation is needed to facilitate registration with FDA. So, the study is open in countries in Europe at the moment, and we are seeing other countries opening up around the world as the CTA gets approved, including Japan, and there are more countries still to come. We are making good progress with the FDA, and we anticipate that we will be able to enroll patients in the U.S. in the foreseeable future once we've resolved the issues around that with them. So we anticipate that there should be representation of the U.S. in the study.

And I guess separately given given some of the enrollment issues that you faced with these initial studies can you just talk about your confidence around being able to enroll the phase III quickly. Thanks.

Okay.

Janet Hammond: The confidence around enrolling the phase 3 study is really that I think it's a very similar population to the outpatient study. We're looking for patients with mild to moderate COVID-19. I think it's a lot less interventional, I would say, than the phase 2 study, which I think makes it a lot more patient friendly for people to want to participate. We're not collecting the pharmacokinetics, et cetera, and all of the viral loads that we are collecting in the phase 2 studies. From that perspective, we're pretty confident that this ought to be considerably easier for patients and has a significantly larger footprint because it's a less intense and less specialized study. We believe that study will actually enroll considerably faster.

So the.

The conference and surrounding rolling the Phase III study is Randy that I think it's it's a very similar population to the and outpatient study we're looking for patients with mild to moderate COVID-19, I think it's and it's it's a lot less intervention will I would say than the phase two study, which I think makes it a lot.

Eric William Joseph: Okay, thanks for taking the questions. I'll hop back into you. Your next question is from Matthew Harrison on behalf of Morgan Stanley. Your line is open.

Matthew Harrison: Great, good afternoon, thanks for taking the questions. I guess two for me. First, on the first dosing cohort, assuming that's what we get in terms of interim data, can you maybe help us think about what you know from drug levels and exposure about what you think is reasonable to expect in terms of viral load decline in those patients. And then, separately, given some of the enrollment issues that you faced with these initial studies, can you just talk about your confidence around being able to enroll phase three quickly? Thanks.

And more patient friendly for people to want to participate we're not collecting the pharmacokinetics et cetera, and and all of the viral loads that we are collecting and the phase two studies. So from that perspective, we're pretty confident that this ought to be considerably easier for patients and it has it has a significantly larger footprint because it's at today.

Less intense and less specialized studies and.

We believe that that study will actually and will consider if he foster and we have more than 150 sites identified for that study. So we anticipate that it ought to be able to go pretty quickly with regard to the phase two studies the dose selected for their studies with selected on experience without dosing of <unk>.

Janet Hammond: We have more than 150 sites identified for that study. We anticipate that it ought to be able to go pretty quickly. With regard to the phase 2 studies, the dose selected for those studies was selected on experience with our dosing of AT-527 in hepatitis C and the modeling derived from that, and also from some preclinical modeling that we have, and also the phase 1 study that we conducted in December, which again corroborates the data that we already had and supports the dose that we have already selected for that. We're pretty confident that the dose ought to be the correct dose in order to see a good antiviral effect.

Janet M. J. Hammond: So the confidence around enrolling in the Phase 3 study is really that I think it's a very similar population to the outpatient study. We're looking for patients with mild to moderate COVID-19.

Five to seven and hepatitis C and the modeling derived from that and also from some preclinical modeling that we have and also the phase one study that we conducted in December which again corroborate the day, so definitely already had and supports the day that we have and already selected for that and so we're pretty.

Janet M. J. Hammond: I think it's a lot less interventional, I would say, than the Phase 2 study, which I think makes it a lot more patient-friendly for people to want to participate. We're not collecting the pharmacokinetics, et cetera, and all of the viral loads that we collect in the Phase 2 study. So from that perspective, we're pretty confident that this ought to be considerably easier for patients and has a significantly larger footprint because it's a less intense and less specialized study.

Confident that the dose or to be the collectors and.

And we'll just see a good antiviral effect and by good antiviral effect, we're anticipating that we would like to see something in the range of what has been seen with the antibody and also with monarch her there and and seen approximately a low drop in and viral load and and the first few days and and all study.

Janet Hammond: By good antiviral effect, we're anticipating that we would like to see something in the range of what has been seen with the antibodies and also with molnupiravir, and in seeing approximately a low drop in viral load in the first few days in our study.

Janet M. J. Hammond: So we believe that that study will actually enroll considerably faster, and we have more than 150 sites identified for that study. So we anticipate that it ought to be able to go pretty quickly. With regard to the Phase 2 studies, the dose selected for those studies was selected based on experience with our dosing of 85 to 7 in hepatitis C, and the modeling derived from that and also from some preclinical modeling that we have, and also the phase one study that we conducted in December, which again corroborated the data that we already had and supports the dose that we have already selected for that.

Okay.

Matthew Harrison: Great. Thanks very much.

Great. Thanks very much.

Janet Hammond: Thank you.

Thank you.

Operator 2: Your next question is from Jonathan Miller from Evercore. Your line is open.

Operator: Your next question is from Jonathan Miller from Evercore. Your line is open.

Your next question is from Jonathan Miller from Evercore. Your line is open.

Jonathan Miller: Hey guys. Thanks for taking the question. Two for me. How should I think about population, or inclusion criteria for the post-exposure prophy trial starting later this year? Is this gonna be similar to the mAbs or a little bit different? How broad is the utility for that indication? Secondly, what's your latest thoughts on the cadence of demand for an oral antiviral in 2022, for instance, given the pandemic course so far this year and where you see it headed?

Hey, guys. Thanks for taking the question.

Through for me, how should I think about population or inclusion criteria for the post exposure appropriate trial. Starting later this year or is this going to be similar to the mobs are a little bit different and how broad is the utility for that indication.

And then secondly.

Are there whats your latest thoughts on the cadence of demand for an oral antiviral in 'twenty. Two for instance, given the pandemic of course, so far this year and where you see it headed.

Janet M. J. Hammond: And so we're pretty confident that the dose ought to be the correct dose in order to see a good antiviral effect. And by a good antiviral effect, we're anticipating that we would like to see something in the range of what has been seen with the antibodies and also with malnipouria and to see approximately a low drop in viral load in the first few days of our study.

So I'll answer the first question and then John perhaps you might want to answer the second.

Janet Hammond: I'll answer the first question and then John, perhaps you might want to answer the second. With regard to the inclusion criteria for our prophylaxis study, we're still actually working on that protocol. I can't really comment or give you too much in the way of specifics. We believe that we anticipate that we will enroll patients down into their teens in our phase 3 study. We anticipate a broad population. We believe that the drug interaction profile for our drug is going to be pretty benign. We would anticipate that this would allow for many patients or people infected with the disease to qualify to take the drug. John, over to you.

And with regard to the inclusion criteria for our prophylaxis study, we're still actually working on that person call.

And I cant really comment and we'll give you too.

Too much and the way of specifics, but we believe that and we anticipate that we will and enroll patients down into that into that teens in our phase III study. So we anticipate a broad population, we believe that the drug and traction profile for a drug that's going to be pretty benign and so we would anticipate that this would.

Matthew Harrison: Great. Thanks very much.

Jonathan Miller: Your next question is from Jonathan Miller from Evercore. Your line is open.

Jonathan Miller: Hey guys, thanks for taking the question.

Jonathan Miller: Two for me, how should I think about population or inclusion criteria for the post-exposure Prophetrile study starting later this year? Is this going to be similar to the MAPs or a little bit different?

Janet M. J. Hammond: How broad is the utility for that indication? And then secondly, what are your latest thoughts on the cadence of demand for an oral antiviral in 22, for instance, given the pandemic course so far this year and where you see it headed? So I'll answer the first question, and then John, perhaps you might want to answer the second.

Allow for many patients or people and substitute the disease to qualify to take with that.

John over to you John.

Jean-Pierre Sommadossi: John?

John Vavricka: Sure. As far as for the ongoing demand for this year and into next year, you know, we continue to see a need for both an oral antiviral and for a vaccine for a couple of reasons. One is the vaccination rates obviously vary particularly in the United States. Two, the introduction of various variants that we continue to see evolve. And with that, even the need that most companies have said that will likely need be a need for a booster. For all of those reasons, we continue to see that the need will continue.

Sure So as force, where the the ongoing demand.

For this year and into next year, you know, we continue to see a need for both <unk> and rural anti Virals and for a vaccine.

For a couple of reasons one is the vaccination rates obviously.

Very particularly in the United States to the introduction of various the variance that we continue to see evolve.

John F. Vavricka: So with regard to the inclusion criteria for our prophylaxis study, we're still actually working on that protocol, so I can't really comment or give you too much in the way of specifics, but we believe that we anticipate that we will enroll patients down into their teens in our phase three study. So we anticipate a broad population. We believe that the drug interaction profile for our drug is going to be pretty benign, so we would anticipate that this would allow many patients or people infected with the disease to qualify to take the drug.

And and with that even the need that most companies have said that will likely be a need for a booster.

And for all of those reasons, we continue to see that there the.

The people will continue.

Jean-Pierre Sommadossi: I think what's important also, just to add to that, John, is that our phase 3, we will have also a follow-up study that will evaluate the impact of direct-acting antivirals such as AT-527 on the long-term sequela that, as you know, is becoming a major issue in 30% to 40% of individuals that got COVID-19. That will even emphasize, if the data are positive, the importance of a DAA also to deal with the long-term sequela of disease.

I think what's important and also just to add to that John is that.

And with our phase III.

We will follow up.

Sorry, the debt.

We'll evaluate the impact of.

Direct acting antivirals, such as 85 to seven on the long term sequela that does you know is becoming a major issue and.

Janet M. J. Hammond: It is a tube. John?

The 240% of individuals and I've got.

John F. Vavricka: Sure, so as far as for the ongoing demand, for this year and into next year, you know, we continue to see a need for both an oral antiviral and a vaccine for a couple of reasons. One is that vaccination rates obviously vary, particularly in the United States. Two, the introduction of the variants that we continue to see evolve. And with that, even the need that most companies have said will likely be a need for a booster. So for all of those reasons, we continue to see that the need will continue.

COVID-19, so that too will even.

And the size.

If the data are positive and the importance of the DAA also too.

Deal with the long term equivalents.

Disease.

John Vavricka: John, one thing I forgot to mention, of course, there was that, when you started asking about post-exposure, or prophylaxis, and in this case, you're seeing testing ramp up around the world. With that, I think you'll see a lot of asymptomatic cases that will be identified, opening up for a direct-acting antiviral as well.

And Jonathan and one thing one thing I forgot to mention of course, there with that.

We just started asking you about post exposure.

Prophylaxis.

And in this case youre seeing testing ramp up around the world and with that I think you'll see a lot of asymptomatic cases that will be identified.

Janet M. J. Hammond: I think what's important also to add to that, John, is that with our phase three, we will also have a follow-up study that will evaluate the impact of direct acting anti-vowels, such as 85 to 7 on the long-term sequela, that as you know is becoming a major issue in 30 to 40% of individuals who got COVID-19. So that will...

Opening up for a.

Direct acting antivirals as well.

Jonathan Miller: Makes sense. One more maybe factual question. Do you have plans for interim analyses in the phase 3? Just so, what those might look like?

Makes sense, one more maybe factual question.

Do you have plans for interim analyses and the phase three and if so what might those look like.

Jean-Pierre Sommadossi: Janet?

Janet.

We will determine whether we need to do an interim analysis at some point I think the pressure policies written and flexibly at the present time, but I don't think I can really comment further.

Janet Hammond: We will determine whether we need to do an interim analysis at some point. I think the protocol is written flexibly at the present time, but I don't think I can really comment further.

Jonathan Miller: And Jonathan, one thing I forgot to mention, of course, Sarah, was that we originally started asking about post-exposure or prophylaxis. And in this case, you're seeing testing ramp up around the world. And with that, I think you'll see a lot of asymptomatic cases that will be identified, opening up the way for a direct-acting antiviral as well. It makes sense. One more, possibly factual question. Do you have plans for interim analyses in phase three, and just so, what might they be?

Jonathan Miller: Thank you very much.

And thank you very much.

Jean-Pierre Sommadossi: Thank you.

Operator 2: Your next question is Tim Lugo from William Blair. Your line is open.

Your next question.

Operator: Your next question is Tim Lugo from William Blair. Your line is open.

Your next question is Tim Lugo from William Blair. Your line is open.

Tim Lugo: Thanks for taking the question and congratulations on the progress. For MORNINGSKY, I understand patients are within five days of symptoms, but I don't see any language about risk factors, you know, similar to the phase 2 program. Can you just maybe clarify the decisions on not kind of enriching for a risk factor? And also, how much sequence data will you be collecting in the trial? I understand it's going to be easier to run, so you don't want it to be cumbersome, but it does seem like there's a risk if you're assuming mAb-like trial behavior, whereas when the mAb trials are run, obviously the genomic makeup of circulating virus right now is significantly different. So maybe just touch upon that.

Thanks for taking my question and congratulations on the progress.

For morning, Sky I understand and patients are within five days of symptoms. So I don't see any language about risk factors.

Similar to the Phase two program can you just maybe clarify the decisions on not kind of enriching.

Janet M. J. Hammond: and just show what those look like. Janice?

For a risk factor and also how much sequence data will you be collecting in the trial and I understand it's going to be easier to run and so you don't want it to be cumbersome, but.

Timothy Francis Lugo: We will determine whether we need to do an interim analysis at some point. I think the Prochopal is written flexibly at the present time, but I don't think I can really comment further. Thank you very much. Your next question. Your next question is Tim Lugo from William Blair. Your line is open.

And it does seem like there is a risk if you're assuming now Blake trial.

Behavior, whereas when the Mab trials are run obviously the genomic makeup of circulating virus right now is significantly different.

Timothy Francis Lugo: Thanks for taking the question and congratulations on the progress. For Morning Sky, I understand patients are within five days of symptoms. If I don't see any language about risk factors, you know, similar to the Phase 2 program, can you just maybe clarify the decisions about not kind of enriching for a risk factor? And also, how much sequence data will you be collecting in the trial? I understand it's going to be easier to run, so you don't want it to be cumbersome.

So maybe just touch upon that.

Yeah.

Janet Hammond: Thank you. With regard to risk factors, we believe that the profile of our drug allows us to look for a broad patient base to treat. The MORNINGSKY study is designed to enroll up to 40% of patients with mild to moderate COVID-19 without risk factors. I should have said, instead of up to, I should have said at least. At least 40% of patients with risk factors, and then the remaining 20% will fall where they may. We plan to capture both populations in that study, really to understand how the drug works in both populations. We think that's important. As Jean-Pierre mentioned already, we think that a direct-acting antiviral has considerable benefit for people with and without risk factors, potentially.

And thank you.

So with regard to risk factors, and we believe that the and profile of our dry and allows us to and look for a broader patient base to treat and so the morning. Sky study is designed to enroll up to 40% of patients with mild to moderate COVID-19 without risk factors and and.

Janet M. J. Hammond: But it does seem like there's a risk if you're assuming MAB-like trial behavior, whereas when the Mab trials are run, obviously, the genomic makeup of the circulating virus right now is significantly different. So maybe just touch upon that. Thank you.

And at least 40, I Should've said and instead of actually I should have said at least and at least 40 percentage of patients with risk factors and then the remaining 20% will fall where they may so we plan to capture both populations and that study Randy to and understand how the drug blocks and both populations and and we.

Janet M. J. Hammond: So with regard to risk factors, we believe that the profile of our drug allows us to look for a broad patient population to treat. And so the morning sky study is designed to enroll up to 40% of patients with mild to moderate COVID-19 without risk factors. And, And at least, I should have said, instead of up to, I should have said at least.

That's important and as John had mentioned already and we think that a direct acting antiviral has considerable benefit for people with and without Chris Clark just to punctuate and then with regard to sequencing we plan to sequence all patients on entry to the study and there are other and time points. During the study when they will undergo sequencing. So we do plan to.

Janet Hammond: With regard to sequencing, we plan to sequence all patients on entry to the study, and there are other time points during the study when they will undergo sequencing. We do plan to have that information available, but not to the same degree of intensity that we're doing in the phase 2 studies, obviously.

Janet M. J. Hammond: At least 40% of patients with risk factors, and then the remaining 20% will fall where they may. So we plan to capture both populations in that study, really, to understand how the drug works in both populations. And we think that's important. And as Jean-Pier mentioned already, we think that a direct-action antiviral has potential to have considerable benefit for people with and without risk factors. And then, with regard to sequencing, we plan to sequence all patients on entry to the study, and there are other time points during the study when they will undergo sequencing.

Have that information available, but not to the same and degree of intensity that we're doing and the phase two studies obviously.

Tim Lugo: Oh, great to hear. And maybe just touching upon sequencing and the variants of concern, can you maybe globally just talk about targeting the RNA polymerase versus some of the other classes of antivirals out there and, you know, what should be a relatively conserved target?

Great to hear and maybe just touching upon sequencing and the variance of concern could you may be globally just talk about.

Targeting the RNA polymerase versus some of the other classes of anti Virals out there and what should be a relatively conserve.

Conserve target.

Jean-Pierre Sommadossi: Tim, from what we see today, actually, unfortunately, India is going to be a breeding ground for variants. So far, the variants from India that have been reported do not affect the miRNA function and do not affect, at least what we have seen so far, any of the amino acids where our drug binds in the RdRp active site. We continue to believe that our drug should be very potent against all variants.

Tim so more to assist today.

And I actually Unfortunately, India is going to be a breeding ground for variance.

And so far.

The variance from India that have been.

Reported.

And do not affect the new and function and and do not upside.

Janet M. J. Hammond: So we do plan to have that information available, but not to the same degree of intensity that we're doing in phase two. Great to hear. And maybe just touching upon sequencing and the variance of concern, can you maybe globally just talk about targeting the RNA polymerase versus some of the other classes of antivirals out there and, you know, what should be a relatively conserved target. Tim, from what we see today,

<unk>.

What we are what do we have seen so far and.

Any of the asset.

Our drug volume and deal deal the.

And the two sides so.

So we we.

And we continue to believe that our drug.

Sure.

And I'd be very important.

John Boyle: Tim, from what we see today, actually, unfortunately, India is going to be a breeding ground for variants. And so far, the variants from India that have been reported do not affect the Niran function and do not affect, at least what we are seeing so far, of the amino acid where our drug binds in the RDRP active sites.

Yes.

Or variance.

Jean-Pierre Sommadossi: As Janet has indicated in the past, the phase 2 hospitalized patient is enrolling patients in South Africa and Brazil, and in Eastern Europe, where there is a significant variant percentage. Finally, the NIAID contract lab, as the variants are now in the server, as I say, we anticipate that they would evaluate AT-511, the free base of AT-527, in in vitro system. I cannot promise that we will have also the in vitro data by the end of June together with the interim virology data.

As China and ASEAN.

Indicated.

In the past.

The phase two us with the life station.

And is enrolling patients and.

Uh Huh in South Africa, and Brazil.

And.

John Boyle: So we continue to believe that our drug should be very potent against all variants, as Janet has indicated. In the past, phase two hospitalized patients were involving patients in South Africa, Brazil, and Eastern Europe, where there is a significant variance percentage. Finally, the NID Contract Lab, as the variants are now, the variance, now, in the NID Contract Lab, as the variance, as I say, we anticipate that they would evaluate 8511, the freebase, of 5 to 7 in the in vitro system.

Eastern Europe, where there was.

Significant.

Variance percentage.

And finally.

And I did contract lab.

As the.

The variance.

Now in December as I say.

And we anticipate that.

They would evaluate.

80, 511, and the the free base.

Oh five to seven and in.

And Vito system, So I cannot promise that we will have also the in vitro data.

And by the.

John Boyle: So I cannot promise that we will also have the in vitro data by the end of June, together with the interim virology data. But definitely, we will have it very early in the third quarter, which obviously would be important to demonstrate also for our phase three. And as soon as we, we hope to have the Indian variant available. We'll do the same. And lastly, all our face to face, especially the hospitalized patient with the global entrant, we have full sequencing at baseline and also after treatment.

The end of June.

All together was the into and virology and data but.

Jean-Pierre Sommadossi: Definitely we will have very early in the Q3, which obviously would be important to demonstrate also for our phase 3. As soon as we hope to have the Indian variant available, we'll do the same. Lastly, all our phase 2, especially the hospitalized patients with the global imprint, we have full sequencing at baseline and also after treatment.

We will love.

Italy and the.

And this third quarter, which obviously would be important to demonstrate also flow faithfully and and that's so that is really we we hope to have the Indian variant available, we'll do the same and lastly.

And all our phase two especially the hospitalized patients was the global income.

We have full sequencing.

Our base line and also still.

Still treatment.

Tim Lugo: Thank you for that color.

Thank you for that color.

Operator 2: I'm showing no further questions at this time. I would now like to turn the conference back to you, Jean-Pierre Sommadossi.

Operator: I'm showing no further questions at this time. I would now like to turn the conference back to you, Jean-Pierre Sommadossi.

Operator: I'm showing no further questions at this time and would not like to turn the conference back to you, John. Here's some of those.

I'm showing no further questions at this time it would like to turn the conference back to you John Kerry somewhat Dorothy.

Jean-Pierre Sommadossi: I'm sorry. Thank you very much for your attention, and we appreciate. Thank you very much.

Oh I'm sorry.

Jean-Pierre Sommadossi: I'm sorry. Thank you very much for your attention, and we appreciate. Thank you very much.

John Boyle: I'm sorry. So, thank you very much for your attention, and we appreciate it. Thank you very much. This is a good conference call today. Thank you for participating. You may now disconnect.

So thank you very much.

Sure.

Yeah attention and.

We appreciate and thank you very much.

Operator 2: This concludes today's conference call. Thank you for participating. You may now disconnect.

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

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

Operator: Thank you.

unknown: and the and so on the way, and so much, you know, and I'm going to be, and I'm going to be.

Yeah.

[music].

And then.

Yeah.

[music].

And.

Hum.

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