Q2 2021 Atea Pharmaceuticals Inc Earnings Call

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Operator: Good afternoon, ladies and gentlemen. Welcome to Atea Pharmaceuticals' second quarter 2021 financial results conference call. At this time, all participants are in listen-only mode.

Good afternoon, ladies and gentlemen, welcome to I can't Pharmaceuticals second quarter 2021 financial results conference call. At this time, all participants are in listen only mode.

Operator: Following the formal remarks, we will open up for your questions. I would now like to turn the call over to Joan A. Barns, Senior Vice President of Investor Relations and Corporate Communications at Attea Pharmaceuticals. Please proceed. Thank you, operator.

The public remarks, we will open up for your questions I would now like to turn the call over to Joe in a bond senior Vice President of Investor Relations and corporate communications at Teva Pharmaceuticals. Please proceed.

Jonae R. Barnes: Good afternoon, everyone, and welcome to Ataya Pharmaceutical's Second Quarter 2021 Financial Results Conference Call. This afternoon, we issued a press release that outlines the topics that we plan to discuss. You can access the press release as well as the slides that we will be reviewing today by going to the investor section of our website at www.ir.ir.com. With me today from Atea are our founder, chairman, and chief executive officer, Dr. John Pierre Somadosa, and Chief Development Officer, Dr. Jamm. Chief Financial Officer, Executive Vice President of Legal, Andrea Corkorin, and our Chief Commercial Officer, John Vavrika.

Thank you operator, good afternoon, everyone and welcome to a K a pharmaceuticals second quarter 2021 financial results Conference call. This afternoon, we issued a press release without lies the topics that we plan to discuss you can access the press release as well as the slides that we'll be reviewing today by going to the investors section of our web.

Site at IR Dot Italia farm, a dot com with me today from our founder Chairman and Chief Executive Officer, Dr. John Peer Summit Joshi, Chief Development Officer, Dr. Jan Hammond, Chief Financial Officer, Executive Vice President of legal and Dray of Corcoran, and our Chief Commercial Officer Dawn.

Jonae R. Barnes: They will all be available for the Q&A portion of today's call. On the call today, we have a lot of important content to review. John Pier will provide an overview of the current COVID-19 environment and AT-527's potential to address these key challenges. Janet will review our clinical progress and results for AT-527 for the treatment of COVID and discuss AT-752 for the treatment of Dengaykeeper.

Breaker, they will all be available for the Q&A portion of today's call.

On the call today, we have a lot of important content to review John's here will provide an overview on the current COVID-19 environment and 85 to seven potential to address these key challenges Janet will review, our clinical progress and results for 85 to seven for the treatment of Covid and discuss 80.752 for the treatment of dengue.

Jonae R. Barnes: John will then provide an overview of the U.S. commercial opportunities for AT527, Drea will provide a financial update, and John Piero will provide closing remarks. Before we begin the call, I would like to remind you that today's discussion will contain forward-looking statements that involve risk and securities. 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 John Pierre.

Cheaper John will then provide an overview of the U S commercial opportunity for <unk> 85 to seven Andrea will provide a financial update and drop here will provide closing remarks before we begin the call I would like to remind you that today's discussion will contain forward looking statements that involve risks and secured.

Securities. 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 John here.

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

Thank you so much.

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

I will begin on slide chewy.

Presentation.

John F. Vavricka: I will begin on slide Shui of the presentation. Since Athea's founding, we have remained steadfast in our mission to discover and develop anti-vowel drugs for the treatment, cure, and prophylaxis of severe viral diseases where there is a significant and unmet medical need where we can make a meaningful impact for patients. Early last year, our anti-vowel platform put us at the forefront in the fight against COVID-19, and we believe a multi-pronged approach, including therapeutics and vaccine, will be essential solutions in this pandemic, which is now becoming endemic. It has become abundantly clear.

Since our founding we have remained steadfast in our mission to discover and develop antiviral drugs will be treated from Q until she likes us to be involved diseases, where there is a significant unmet.

Medical need where we can make a meaningful impact for patients.

Last year, our antibody platform put us at the forefront.

Against COVID-19, and we believe our multi pronged approach, including therapeutics and vaccines will be essential solutions in this pandemic, which is now becoming endemic.

It has become clear.

Phil.

Most countries and regions like Southeast Asia, South America, and India, where we are saying that the vast the thing impact from Covid of low vaccination rates, which have become a showroom covariance and creates new challenges for treatment and prevention. It is projected that the delta value currently a council.

93%.

All new cases in the United States and we are now back to 100000, new infection, but they obviously this is a particular concern given recent publication demonstrating lower efficacy rates for vaccine against the new strain for example, the depth of variance.

John F. Vavricka: Most countries and regions like Southeast Asia, South America, and India, where we are seeing a devastating impact from COVID of low vaccination rates, which have become a source for variants and created new challenges for treatment and prevention. It is projected that the Delta variant currently accounts for 93% of all new cases in the United States. And we have now back to 100,000 new infections today. Obviously, this is a particular concern, given recent publications demonstrating lower efficacy rates for vaccines against the new strength.

So being reported to be highly contagious almost as contagious has chickenpox and he does more rapidly application.

Then just strengths.

This we are seeing a significant number of drag suitcases and vaccinated 40 vaccine 80 patients accounting for as much as 15%.

All hospitalized patients and even 15% of the new cases now in children, which further expand the infected population.

Vision to the Delta variant the Lambda variant firstly identify in Peru, and I was scribbling in South America. He was a highly infectious as well.

Diluted concerning and I'm sure that in six months or so.

We would probably talk about I know the dominant variance in the U S and other countries.

John F. Vavricka: For example, the Delta variant has also been reported to be highly contagious, almost as contagious as chickenpox, and it has a more rapid replication than earlier strains. And for this, we are saying a significant number of drug-through cases and vaccinated, fully vaccinated patients, accounting for as much as 15% in all hospitalized patients, and even 15% of the new cases now are in children, which further expands the infected population. In addition to the Delta variant, the Lambda variant, first identified in Peru and now spreading in South America.

Turning to slide Paul given these evolving dynamics Medicare convention that old therapeutics in particular will be essential in stemming the tide of this pandemic, we believe that 85 to seven.

All he administered <unk>.

Acting antiviral, Egypt derived chromo QE nucleotide prodrug platform is uniquely positioned to help meet this challenge and become the solution.

As I'm sure by now you know 85 to seven targets viral RNA polymerase, which is a highly conserved enzyme critical to viral application in transcription and this was this dual mechanism.

<unk> both are.

Functional domains of this island preliminaries inhibiting both Nee Randall.

We believe that we provide the high barrier to resistance along with broad antiviral coverage for different variants of Sars Cov two.

John F. Vavricka: These are highly infectious as well, and particularly concerning, and I'm sure that in six months or so, we will probably talk about another dominant variance in the U.S. and other countries. Turning to slide four, given this evolving dynamics, medical convention and all therapeutics, in particular, will be essential in stemming the tide of this pandemic. I believe that 85 to 7, our poorly administered direct acting anti-val agent derived from our pure nucleotide project platform, is uniquely positioned to help meet this challenge and become a solution. As I'm sure now, you know, 85 to 7 targets viral RNA polymerase, which is a highly-conserved enzyme critical to viral replication and transcription.

To date.

Predominant mutation naturally and this I wouldn't they preliminaries is the peak suite 20, Sweet al and please note our baseline you know hospitalized phase II trials, 98% of the patients add this mutation.

And we believe that all responded.

285 to seven treatment essentially we can say today that.

There is.

A regional war one vial.

This is is basically gone and we believe that this bodes very well for antiviral activity against the variance as well and we are currently validating this I participate.

As reported in recent press releases.

A significant amount of compelling clinical data that's been reported for all the drugs demonstrating anti viral efficacy in our phase II study in the us capitalize patients and today Janet the way we viewed the phase two interim results as well as new data Bronchoalveolar Lavage study.

John F. Vavricka: And this, with its dual mechanism affecting both functional domains of this RNA polymerase, inhibiting both NIRAND and the RDRP, we believe that we provide a high barrier to resistance, along with broad antiviral coverage for different variants of South Corps 2. To date, the predominant mutation in this RNA polymerase is actually the P323L. And please note, at baseline in a hospitalized phase two trial, 98% of the patients had this mutation, and we believe that all responded to 85 to 7 treatment. Essentially, we can say today that the original war viruses are basically gone.

Demonstrating that 85 to seven we believe is the first investigational DAA being they will probably 19 and showing that target drug levels effectively.

The lungs, which as you know is the primary sites or Sars cov, two infection I want to emphasize that this is the lower respiratory track and contrast, where we are measuring the M&A I've tried to show you and share with you. The data we are talking about upper respiratory track.

So that's why we view this data.

It's very important for our development program.

As they provide further confidence not only for the treatment, but also for plan prophylaxis studies for COVID-19.

As we continue to advance multiple global clinical studies in parallel with our partner Roche, we are once that closer to achieving our goal of providing an easily administered all direct acting antiviral in the fight against this global pandemic and now I would like to turn the call to Janet.

John F. Vavricka: And we believe that this also bodes very well for antiviral activity against the variance as well, and we are currently validating this hypothesis. As reported in a recent press release, a significant amount of compelling clinical data has been reported for our drugs, demonstrating antiviral efficacy in our phase two study in hospitalized patients. And today, Janet, we review the phase two interim results, as well as new data on a Grosurva-Lavash study, demonstrating that 85-7, we believe, is the first investigation of DAA being developed for COVID-19, ensuring that target drug levels effectively reach the lung, which, as you know, is the primary site of South Coast II infection.

For a full review of these data Janet.

Thank you Cynthia.

I'll begin with slide SEC.

And the COVID-19, pandemic evolves and we generate more cases on AC pasture second program.

Yeah, nimbly to optimize the design and conduct with Occidental development program.

And you can see here, we have six studies of 85 to seven currently running in parallel.

We're leveraging lessons learned from each study to best serve our patients and improve our probability of success.

Slide seven outlines our global Phase two study of 85 to seven in the hospital setting.

Before we review the interim results.

Reminder, this is a randomized double blind placebo controlled multi center study to evaluate 85 to seven in patients with COVID-19.

John F. Vavricka: I want to emphasize that this is the lower respiratory tract, in contrast to where we are measuring the RNA, as Janet will show you and share with you the data. We are talking about the upper respiratory tract. So that's why we view this data as very important for our... develop a program as they provide further confidence, not only for the treatment but also for our planned prophylaxis studies for COVID-19. As we continue to advance multiple global clinical studies in parallel with our partner Roche, we are one step closer to achieving our goal of providing an easily administered or direct acting and thereby facilitating the fight against this global pandemic. And now I would like to turn the call over to Janet for a full review of this data. Janet.

Study objectives are to assess safety tolerability clinical and antiviral efficacy.

That's Hershey amending the protocol to assess the evolving COVID-19 environment like changing the primary endpoint of virology.

Question tourists fishing proficiency.

The limited number of cases have now progressed.

Changes in the standard of care.

We will also be exploring alternative doses and adding a policy cohort comprised of up to 110 persons.

Moving to slide eight.

In Chile, we were delighted to announce positive interim results from our careful phase two study of 85 to seven.

Indicating one and sustained antiviral activity against Sars Covid two in patients with COVID-19 in the hospital setting.

The interim analysis of the phase two study indicated data from Stephens hospice nice high risk patients with COVID-19 from which 62 patients who are evaluable.

Janet M. J. Hammond: I'll begin with slide six. As the COVID-19 pandemic evolves and we generate more data from our 8527 program, we are acting limbly to optimize the design and conduct of our clinical development program. As you can see here, we have six studies of 8527 currently running in parallel, and we're leveraging lessons learned from each study to better serve our patients and improve our probability of success. Slide 7 outlines our global phase 2 study of 85 to 7 in the hospitalized setting.

Virological anomaly.

These patients were infected with a broad array of Archie niches, representing over 20 variance and included the alpha and beta variance of concern.

They were enrolled from certain countries in North America, Europe Africa, and South America, representing a diverse geographic footprint.

46% of patients with Sars Covid, two seropositive by IGN measurement at baseline and well equally distributed across the treatment arms.

As expected and observed in other studies seropositive patients have never they signed down there.

Continue to found a decline from the onset of respiratory tract infection is cautious a natural history of these diseases and it's to be expected.

What is important is the differential rates of decline of virus driven by the administration of a direct acting antiviral.

Janet M. J. Hammond: Before we review the interim results, as a reminder, this is a randomized, double-blind, placebo-controlled, multicentre study to evaluate 85-27 in patients with moderate COVID-19. Study objectives are to assess safety, tolerability, clinical, and antiviral efficacy. They're currently amending the protocol to reflect the evolving COVID environment by changing the primary end point to virology from its former progression to respiratory impositioncy, owing to the limited number of cases that now progress due to changes in the standard of care. We will also be exploring alternative doses and adding a Part B cohort comprised of up to 110 patients. Moving to slide 8.

The low of the viral days.

The risk of kind of smoothing infection and.

And the greater the likelihood that the immune system is able to deal with whatever remaining virus as president.

And help to shorten and the disease.

On slide nine.

All evaluable patients with stage two patients receiving 85 to seven experienced seven love 10 dropped in Bangladesh.

Which is an 8% mean reduction from baseline viral load in comparison with the placebo group.

Our sustained difference in viral load reduction between the two cohorts with maintained all the way through to a.

With the statement that we are seeing a rapid and strong antiviral signal and this is critical as the value and to meet the health impact of a D. A M is to rapidly inhibit viral replication in the early phase of infections and reduce disease progression.

85, deafness Sars Covid two person to antiviral activity was consistent across multiple pre specified analyses.

And again as expected on slide 10 was more pronounced in subjects in writing with high of Ireland.

Janet M. J. Hammond: In June, we were delighted to announce positive interim results from our global phase two study of 83527, indicating rapid and sustained antiviral activity against SARS-COV2 in patients with COVID-19 and in hospitalized settings. The interim analysis of the phase two study included data from 70 hospitalized high-risk patients with COVID-19, from which 62 patients were available for virological analysis. These patients were infected with a broad array of virus lineages, representing over 20 variants and including the alpha and beta variants of concern.

On slide 11 as measured by Nasopharyngeal swabs.

Let's see PCR test with a lower level of quantification of less than 500 cookies.

You can see in the graph to the left at the earliest stage two attestation, 42% to patients in the 85 to seven on the Chiefs all Karen.

Compared to Europe.

Placebo.

In the graph to the right when you're evaluating a stricter thresholds with no detectable RNA virus or target not detected P. M D.

Still especially 3% of patients in the 85 to seven of them had undetectable RNA at day 10.

And you have pizza negativism demonstrations in these phase two results maybe.

Maybe a faster recovery time.

Olson minimizing the transmission of infection.

In this phase two study consistent with previous studies 85 through seven was generally safe and well tolerated and there were no drug related serious adverse events.

Janet M. J. Hammond: They were enrolled from seven countries in North America, Europe, Africa, and South America, representing a diverse geographic area. 46% of patients were SARS-KV2-3-positive by IGM measurement at baseline and were equally distributed across the treatment arms. As expected and observed in other studies, seropositive patients had lower baseline viral load. Continued bowel decline from the onset of a respiratory tract infection is part of the natural history of these diseases and is to

Now moving to slide 12.

You'll find yourself, yeah that evaluates at current levels measured in the lung 19, Suez and this is called a bronchoalveolar lavage study and measure drug levels from the surface of the lung and some cells in the lungs of pain to washing that came from the lungs.

For the first time with a direct acting antiviral target blood levels were achieved in the lungs in healthy volunteers and it's 85 to 750 milligrams administered twice daily.

And these levels even exceeded the target 0.5, my canola over 159 milligrams timidity, something which corresponds to the in vitro <unk> 90 of the guidance and in fact are currently humans.

The female town.

This is important in confirming that 85 to seven week target drug levels at the primary sites of infection.

Janet M. J. Hammond: What is important is the differential rate of decline of the virus driven by the administration of a direct acting antiviral. The lower the viral load, the lower the risk of transmitting infections, and the greater the likelihood that the immune system is able to deal with whatever remaining virus is present and help to shorten and attenuate the disease. On slide nine, In all available patients at day two, patients receiving 85-27 experienced a.7 log pain drop in barrel load, which is an 8% greater mean reduction from baseline viral load in comparison with the placebo group.

And has significant implications for efficacy in both treatment arms person axis because it 19.

As seen on slide 13.

This is a sars COVID-19 two infected cells treated with 80.511, which is the free basis 85 to seven five next generation sequencing confirm that 85 to seven is not in Houston and it does not introduce mutations into the viral genome.

Such mutations we believe could be the catalyst for new variants, especially in immunocompromised patients.

In addition in Europe drug drug interaction study in healthy volunteers indicates that 85 to seven is a weak inhibitor of six three a M.

No dose adjustments should we need it for co administration of drugs that are six three substrates.

Three as of the most abundant cash comes in the human liver and are accountable for the metabolism of more than 50% of clinical drugs.

Janet M. J. Hammond: A sustained difference in viral load reduction between the two cohorts was maintained all the way through day eight. With this station set, we are seeing a rapid and strong antiviral signal, And this is critical as the value and immediate health impact of the DAA is to rapidly inhibit viral rectication in the early phase of infection and reduce disease progression. 85 to 7 SARS-COV2 potent antiviral activity was consistent across multiple pre-specified analyses, and again, as expected, on slide 10, was more pronounced in subject in rolling with higher, On slide 11, as measured by nasoparyngeal swabs in an RT-PCR test with a lower level of quantification of less than 500 copies, You can see in the graph to the left, as early as day two and at day 10, 42% of the patients in the AT 527 arm achieved bowel care, compared with 0% in the placebo arm.

So this should make prescribing Simpson.

Moving to slide 14.

So.

Terrible phase two trial of 85 to seven in the outpatient setting continues to advance.

It's a randomized double blind multi center placebo controlled trial evaluating 85 to seven in mild to moderate COVID-19 outpatient.

Being conducted in collaboration with Roche and will enroll up to 220 patients to evaluate the antiviral activity safety and pharmacokinetics of 85 to seven in adult patients.

The primary endpoint of this trial is change from baseline in the amount of Sars Covid two virus RNA.

As measured by reverse transcription polymerase chain reaction a specified time point.

There are multiple cohorts with varying doses and we expect results in the second half of this year.

The late Q3 or early Q4.

Enrollment in COVID-19 studies is challenging across the industry and we're continuing to open additional clinical sites, which is helping with recruitment.

This is a surprisingly challenging disease for clinical trials and that is spreading around the world is unpredictable.

Menu without seasonality and when patients do the kind of infection. There is a very limited window for eligibility for entry into our studies.

Nick This is a phase two proof of concept study to show antiviral activity.

She stays in catalysis, and importantly to confirm the safety profile of the drug.

The study has nothing powered for statistical significance.

Janet M. J. Hammond: In the graph to the right, when evaluating a stricter threshold with no detectable RNA virus or target not detected, T&D, still 33% of patients in the AT-527 arm had undetectable RNA at day 10. This, as you have PCO negativity as demonstrations in these phase two results, may lead to a faster recovery time while also minimizing the transmission of infections. In this phase I study, consistent with previous studies, AT5-27 was generally safe and well- tolerated, and there were no drug-related, serious adverse events.

As highlighted on slide 15.

We continue to advance our phase III morning, Sky trial, a global multi center trial evaluating <unk> five to seven in mild or moderate COVID-19 patients in an outpatient setting.

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

We anticipate that it will enroll approximately 14, Harper's adults and adolescents with mild to moderate COVID-19.

Patients with or without risk classes will be randomized within five days of symptom onset.

At the time of enrollment patients left to stable enough across the sensation.

The primary endpoint evaluating the efficacy of 85 to seven compared with placebo will measure the time to a deviation or improvement as COVID-19 symptoms.

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

Janet M. J. Hammond: Now moving to slide 12, you'll find new results here that evaluate drug levels measured in the lung lining. This is called a broncho alveola lavage study and measures drug levels from the surface of the lungs and from cells in the lungs, a pain through washing away the pain from the lung. For the first time with a direct acting antiviral, target drug levels were achieved in the lungs in healthy volunteers with AT 527, 550 milligrams administered twice daily.

And also mortality.

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

We currently expect results from this study in the second half of 2021.

Patients from the study has the option to roll over into major spring.

<unk> three six month long term follow on study conducted in collaboration with Roche.

This trial was recently initiated and will evaluate the impact of 85 to seven on non Covid.

It is expected to enroll approximately 1000 patients and is already currently accruing patients.

Janet M. J. Hammond: And these levels even exceeded the target 0.5 micromolar or 150 nanogram per milliliter, which corresponds to the in vitro E.c90 of the drug in infected primary human airway epithelial. This is important in confirming that AT5 to 7 reaches target drug levels at the primary site of infection, and has significant implications for efficacy in both treatment and prophylacis for COVID-19. As seen on slide 13, analysis of SARS-COV-2 infected tails treated with AT511, which is the free base of 8527, by next-generation sequencing confirmed that 8527 is not a mutagen, and it does not introduce mutations into the viral genus.

Let me now turn the corner over to John for an 85 to seven commercial laptops.

John.

Thank you Janet.

Turning to slide 17.

We tend to view the target population for broad patient segments.

They're symptomatic active disease in which a patient with symptoms are present and be treated.

Asymptomatic active disease and all the other asymptomatic. We believe these patients will be accessed through proactive testing some employers schools and travel.

And the third area is prophylaxis for pre and post exposure and finally at government purchase which would include <unk>.

Purchases, both for active disease as well as for stockpile and we see all of these segments as large.

The large the large market opportunity.

We also considered important to look at that David and Unvaccinated people in each of these segments when considering different patient motivation and communication.

Compared to the last pandemic with each one and one and 2009 one of the biggest differences was that there were FDA approved anti virals readily available.

The government chose to stockpile during the pandemic.

Current government efforts appear to target availability.

Oral therapeutic treatments for COVID-19, and our met our met for immediate utilization within the U S distribution system, following an EUA or an NDA approval.

Janet M. J. Hammond: Such mutations, we believe could be the catalyst for new variants, especially in immunocompromise patients. In addition, a new drug-drug interaction study in Healthy Volunteers indicates that AT5-27 is a weak inhibitor of SIP-3A and that no dose adjustments should be needed for co-administration of drugs that are SIP-3A subs. Tip 3As are the most abundant ptachromes in the human liver and are accountable for So this should make prescribing simple. Moving to trade 40.

There is currently a $3.2 billion government offering oral therapeutic treatments or.

Or harvest that patients mild to moderate patients and pre and post exposure prophylaxis treatment.

And we remain in active discussions with the U S government agencies regarding this offering.

We also believe that given the devastating global impact of COVID-19, it is highly likely that the U S government.

<unk> also stockpiled features for future.

Similar to what they stockpiled during H one N one.

With that overview I'll now turn the call back over to you.

Yeah.

Thanks, John.

On slide 19, I am pleased to report that we are also making progress with a T. CEP in size to our program for dengue.

Janet M. J. Hammond: Monson, our glurable phase two trial of AT 5 to 7 in the outpatient setting continues to advance. It's a randomized, double-blind, multi-center, placebo control trial evaluating 8527 in mild or moderate COVID-19 outcomes. It is being conducted in collaboration with Roche and will enroll up to 220 patients to evaluate the antiviral activity, safety, and pharmacokinetics of AT527 in adult patients. The primary endpoint of this trial is change from baseline in the amount of SARS-Kalbid to virus RNA, as measured by reverse transcription and polymerase chain reaction at specified times. There are multiple cohorts with different results, and we expect results in the second half of this year, either late Q3 or early Q4.

The phase one single ascending dose study portion of the trial evaluating multiple doses have been successfully completions and the multiple ascending dose portion of the trial was initiated during this quarter.

The objective of the study is to establish the safety and Tolerability of <unk> 75, two and also to support dose selection for future studies at 80.752 is a treatment and also for person actresses dengue fever.

It is expected to grow up to 60 patients.

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

Yeah.

Thank you Janet.

SG&A mentioned in her introductory remarks. This afternoon, we issued a press release containing our financial results for the second quarter of 2021.

Statement of operations and balance sheet are on slides 21, and 'twenty two.

For the second quarter 2021, the increase in research and development expenses in comparison to the second quarter of 2020 was principally driven by an increase in external clinical development and manufacturing expenses.

Primarily in conjunction with the advancement of 85 to seven for the treatment of COVID-19, and to a lesser extent 80, 752, which is being developed for dengue fever.

Janet M. J. Hammond: Enrollment in COVID-19 studies is challenging across the industry, and we're continuing to open additional clinical sites, which is helping with recruitment. This is a surprisingly challenging disease for clinical trials in that its spread around the world is unpredictable, seemingly without seasonality. And when patients do become infected, there is a very limited window for eligibility for entry into our study. Note that this is a phase two proof-of-concept study to show antiviral activity, supportive data for dosage, and importantly, to confirm the safety profile of the drug. The study has not been powered for statistical significance. And I'm sorry for some slides.

These expenses included our share of cost incurred by Roche and increases in term spend mostly 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 consist principally and an increase in payroll and personnel related expenses.

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

As of June 32021, cash and cash equivalents were $816.5 million.

Please note that this does not include the $50 million development milestone the company achieved in June under a license agreement with Roche that payment was received in July.

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

Thank you Andrea and closing.

Janet M. J. Hammond: We continue to advance our phase three morning sky trial, a global multi-center trial evaluating 8527 in mild or moderate COVID-19 patients in an outpatient setting. This trial is being conducted with our partner Roche, and it is currently enrolling patients outside of the United States. We anticipate that 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.

Not under estimate the importance of the 85 to seven clinical development program and the progress we are making.

The COVID-19 endemic remains very much with us and all data point.

A lot of shows this fall due to the delta variance and little vaccination rates around the world.

It is our goal to advance this important program.

To provide rapidly a solution that can play an important role in helping to reduce the global burden of this disease.

Tanger team along with our partners at Roche.

Doing everything in our power to make this happen our success would be every one success as reviewed today, we continued to make substantial progress with HCP price to Simon and.

We have demonstrated that 85 to seven as rapid and sustained antiviral activity against Sars cov, two richest target drug level in the lungs, which as you know is the primary site of infection.

Janet M. J. Hammond: The primary endpoints, evaluating the efficacy of AT527 compared with placebo, will measure the time to alleviation or improvement of COVID-19 symptoms. Other key efficacy endpoints will include the number of patients requiring medically attended visits or hospitalization for COVID-19 and also mortality. Additionally, among other secondary and extra-intestinal ends, the study will also identify and or evaluate biomarkers that are predictive of an antiviral response to A.T.527. We currently expect results from this study in the second half of 2021.

Our unique dual mechanism targeting the island, a pretty boys, which we believe will be important for a high barrier to resistance and hopefully also.

Addressing the problem that we are seeing with the veins.

<unk> does not commit to Jim very likely not leading to new variance in the future.

And no dose adjustments necessary for co administration of drugs that are shipped three a substrate as you know and Jeremy as indicated.

The largest majority of drug being metabolized by these enzymes.

We continue to advance multiple global clinical studies in parallel with our partner Roche, we look forward to the upcoming upcoming results from the phase two months song of the Phase III mornings guys studies. In addition to the substantial progress was 85 seven we continued to make progress with Europe drug candidate.

Janet M. J. Hammond: Patients from this study have the option to roll over into major spring, a phase three six-month long-term follow-on study conducted in collaboration with Roe. This trial was recently initiated and will evaluate the impact of AT 527 on Lom COVID. It's expected to enroll approximately 1,000 patients and is already currently accruing patients. Let me now turn the call over to John for an AT527 commercial. John?

It's you know anti volume onto our own pipeline for the trailer dengue. It. Besides C&I was b and we expect to provide an update on these programs later this year with that operator, we will now open the call to your questions.

Thank you as a reminder to ask a question you will need to press star one on your telephone to withdraw your question press the pound key please standby, while we compile the Q&A roster.

And your first question comes from the line of Eric Joseph with JP Morgan.

Hi, good evening, thanks for taking the question.

John F. Vavricka: Thank you, Janet. Turning to slide 17. We tend to view the target populations as four broad patients. There is symptomatic active disease, in which a patient with symptoms would present and be treated. There's asymptomatic active disease, and although they're asymptomatic, we believe these patients will be accessed through proactive testing from employers, schools, and travel. And the third area is prophylaxis, both pre and post exposure, and finally, government purchase, which would include purchases both for active disease as well as for stockpiles. And we see all of these segments as large market opportunities.

I'm sure. There's a couple of from US I guess first with as it relates to the phase III in patient data I'm curious to know whether at this stage.

What are the field kind of has a sense of how the normal decay of viral load mirrors on too.

Symptom improvement or symptom resolution I guess, if we're trying to relate the compare the comparative viral load data in the phase II study.

Is there sort of an absolute threshold of viral load that might predict for symptom resolution.

Or is kind of a goal trying to get to viral.

Beryl clearance.

As a greater.

Greater proportion of patients as possible.

And then secondly.

J P. You highlighted the unmet need in the pediatric population I would be curious to know whether there are any plans to kind of begin.

Safety testing and if Peter Alex.

P J.

Activation.

Expand actually step up.

John F. Vavricka: We also consider it important to look at vaccinated and unvaccinated people in each of these segments when considering different patient motivations and communication. Compared to the last pandemic with H1N1 in 2009, one of the biggest differences was that FDA-approved antivirals were readily available so that the government chose to stockpile during the pandemic. Current government efforts appear to target the availability of new oral therapeutic treatments for COVID-19 and are meant for immediate utilization within the U.S. distribution system following an EUA or an NDA approval.

That opportunity. Thank you.

Two great questions Charlie Thank you.

Janet.

Maybe address both questions.

Thank you Jeff here, you're happy to.

They're testing in regard to your question around the symptoms in comparison to what happens to the viral.

Okay.

Overall cohorts of patients and it's a very small cohort of patients.

We didn't see much of it much of a correlation between symptom decline and viral load decline. However, when we looked at the patient group, who have borrowed is in excess of the medium term.

And five to six clubs.

We actually saw.

Surprisingly good.

Good correlation between declining violence and declining symptoms and so.

What that would translate to then was really that the violent decline in patients who are treated.

John F. Vavricka: There is currently a $3.2 billion government offering for oral therapeutic treatments, or hybrid outpatients, mild to moderate, and pre and post-exposure prophylaxis, and we remain in active discussions with the U.S. government agencies implementing this offering. We also believe that given the devastating global impact of COVID-19, it is highly likely that the U.S. government will also stockpile treatments for future preparedness similar to what they stockpiled during With that overview, I'll now turn the call back over to China. Thanks, John.

It wasn't associated with a very much more rapid.

Improvements in symptoms and approximately a two day yeah overall.

Time to resolution of symptoms.

So I think that answer that question and then in regard to the pediatric population. Yes, we are already in talks with both the EMA and the FDA in regards to a pediatric trial and those agencies have seen the plan and have provided comments to.

To that and actually I think as I've mentioned in a morning Sky study, we do have plans to start enrolling adolescence into that study because obviously, it's going to be a really important patient population.

That's b treatment, particularly as it's taking longer for the vaccines turned off.

Thank you.

Great. Thanks for taking the questions.

The next question comes from the line of Jonathan Miller with Evercore.

Thanks for taking my question.

John F. Vavricka: On slide 19, I'm pleased to report that we are also making progress with AET752, our program for Gengi. The phase 1A single ascending dose study portion of the trial, evaluating multiple doses, has been successfully completed, and the multiple ascending dose portion of the trial was initiated during this quarter. The objectives of the study are to establish the safety and tolerability of 8752, and also to support dose selection for future studies of 8752 as a treatment for dainly fever, is expected to involve up to 60 patients. With that, I'll now turn the call over to Andrea for a review of the financials. Thank you, Janice.

First one on the big Phase III, what percentage of the patients do you expect to be zero negative AD baselines and says we've seen another direct acting antiviral trials that have been responsible for driving the majority of the benefit.

And secondly.

We've seen some recent positive results in post exposure prophylaxis trials done with monoclonal antibodies.

And we've been wondering how you think that reads through to oral small molecule approach can you do even better worse and remind me what your timeline is for initiating some sort of a therapy trial, where there pre or post our exposure.

Jaret.

Okay.

With regard to the proportion of patients who are going to be fair a negative I think to some extent and my interpretation of the literature to date has been that actually patients who are more in a compromise and who have far how viral alerts tend to tend to be sort of negative inflation to have fewer of them.

Classes are not generally.

And in better shape tend to have no.

With our owners and all systems are a positive.

Andrea J. Corcoran: As Jonae mentioned in her introductory remarks, this afternoon, we issued a press release containing our financial results for the second quarter of 2021. The Statement of Operations and Balance Sheet are on slides 21 and 22. For the second quarter of 2021, the increase in research and development expenses in comparison to the second quarter of 2020, 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 is being developed for dengue fever.

I think that's it for our phase III studies, where we're planning to enroll this high and low risk patients.

Really two well both populations into a stimulus into single study I think it's likely that we will see more patients who tend to be very positive or negative because of the fact that we will have the patients too.

Already their risks and like you said is there a positive and then the patients who are at high risk I think as you saw we're not hospitalized study approximately.

50% of patients, where sera positive or negative so.

So I'm guessing that bank will translate into a higher proportion of patients being <unk> positive.

You're right. It's a great question, because I think one tends to see a better viral response.

Oh, it's more easy to see that correlation in patients who still fulfilling negative just because they have a half hour alert initiative thoughtful.

With regard to your question around page, there's your prophylaxis I think they're all different.

There's some similarities between what we anticipate seeing I think we anticipate that a pre exposure prophylaxis.

Andrea J. Corcoran: These expenses included our share of costs incurred by Roche and increases in internal spending mostly 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 second quarter with a strong balance sheet to support our clinical development program. As of June 30, 2021, cash and cash equivalents were $816.5 million.

To deliver similar levels of benefit to what you see with the antibodies I think that Opex pros and cons to both approaches.

The approach of a small molecule in that type of thing. Obviously is that access is relatively considerably easier in that you don't need to go and get an injection and you can initiate therapy.

Much more convenient.

I think the disadvantage to some extent will be that the monoclonal antibodies have a longer duration of effect after a single dose, whereas the prophylaxis with a direct acting antiviral would be dependent on taking the drug.

Andrea J. Corcoran: Please note that this does not include the $50 million development milestone the company achieved in June under our license agreement with Roche, that payment with receipts into law. I'll now turn the call back over to jump here for closing.

Of course that means that there is more room for catering is and potentially I suppose also ultimately less likelihood for them.

10%.

Of resistance there. So I think we'll have to see how it all evolves and how and what we learned but I think I I think that in general.

Yeah.

There are advantages and disadvantages to both purchase that I, we believe that the antiviral efficacy for both precious obviously, they're similar.

John F. Vavricka: Thank you, Andrea. In closing, we cannot underestimate the importance of the 85 to 7 clinical development program and the progress we are making. The COVID-19 endemic remains very much with us, and all data points to another search this fall due to the Delta variant and low vaccination rates around the world. It is our goal to advance this important program and to provide a solution that can play an important role in helping to reduce the global burden of this disease. The Atea team, along with our partners at Roche, are doing everything in our power to make this happen. Our success would be everyone's success.

And your plans to initiate this trial.

I'm, sorry, sorry, yeah, and we plan to initiate the trial in the second half.

Thanks very much.

Your next question comes from the line of Tim Lugo with William Blair.

Hey, guys. This is lachlan on for Tim. Thanks for taking my questions first of all I just wanted to clarify when you said that morning Sky only globally did that include the.

U S.

The FDA.

The way that a bit in the past, but I just wanted to check about something Ronnie.

And second you've said that you're looking at higher doses can you share any details on what that higher dose is when we might see the first data from that is that going to be with the Morningstar readout.

Q3 Q4.

And how much incremental efficacy you might expect to see from that especially given the bronchial alveolar lavage.

Oh sure.

Okay.

Hum.

I'll get you to address the second one.

John F. Vavricka: As we viewed today, we continue to make substantial progress with 85-27, and now we have demonstrated that 85-7 has rapid and sustained antiviral activity against SARS-CoV-2, reaches target drug level in the lungs, which, as you know, is the primary site of infection, a unique dual mechanism targeting the RNA polymerase, which we believe will be important for high barrier to resistance, and hopefully also for addressing the problem that we are seeing with the variance, demonstrated that it is not a metagen, very likely not leading to new variants in the future, and no dose adjustment necessary for co-administration of drugs that are C3A substrate, as you know, and Janet has indicated, the largest majority of drug being metabolized by these enzymes. As we continue to advance multiple global clinical studies in parallel with Alpano Roche, we look forward to the upcoming results from the Phase 2 Monsong and the Phase 3 Morning Sky's studies.

In China towards over the first one look first we anticipate that.

We should.

To.

Bushnell.

Increase.

And those concentrations.

And <unk>.

And then two we don't have to.

Data obviously.

We cannot make some extrapolation, but.

From the data that we see in that.

From the phase one.

That's ongoing at higher doses.

We believe that there is going to be substantial.

Drug exposure increase.

Fully.

Sure.

Translate in the embedded anti viral efficacy and ultimately a clinical benefit.

So we are encouraged by the fact that we continue to see the same tolerance.

And safety.

And obviously.

We have two two expanding larger cohort now.

Which study will show the results.

Janet.

Indicated we have six studies in parallel and and as soon as the court will be completed that will will share was was it was it was the street Kevin do you want to address the first question.

John F. Vavricka: In addition to the substantial progress with 85 to 7, we continue to make progress with the other drug candidates in our antiviral pipeline for Trinodeal Dengi, hepatitis C, and RSV, and we expect to provide an update on this program later this year.

So the first question I think was it in regard to morning Sky was a turnkey and learning from you all.

And the answer to that is no it.

It is not.

Discussions with the FDA and that is currently not hurting the U S.

Okay, Thanks, and just a follow up on that.

Given any guidance as to how much.

How many patients.

Operator: Thank you. As a reminder to ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the pound key. Please stand by until we can follow the Q&A roster. And your first question comes from the line of Eric Joseph.

They need to see to allow them to enroll.

A sense of when that might be able to get up and running.

Yeah.

Hi, Kevin.

Any comment on those types of specifics Unfortunately is that enough to able to answer your question.

Got it thanks.

Okay.

As a reminder to ask a question you will need press star one on your telephone to withdraw your question press the pound key.

Yeah.

Eric William Joseph: Hi, good evening, thanks for taking the question. There are a couple of questions from us. I guess first, as it relates to the space two inpatient data, I'm curious to know whether, at this stage, the field kind of has a sense of how the normal decay of viral load mirrors symptom improvement or symptom resolution. I guess if we're trying to relate the comparative viral load data in the phase two study, is there sort of an absolute threshold of viral load that might predict symptom resolution, you know, or it's kind of a goal trying to get to viral clearance as many, as, as, as, a great proportion of patients as possible.

Yeah.

And your next question comes.

And I'm showing no more questions at this time.

[noise] so.

Yeah.

Thank you everybody for Europe.

Interest and support.

Appreciate and thank you for again for joining us them.

And continuous support structure. Thank you.

Sure.

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

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Eric William Joseph: And then secondly, JP, you highlighted the need in the pediatric population. I'd be curious to know whether there are any plans to kind of begin safety testing in the pediatric population to kind of expand access to that opportunity. Thank you.

John F. Vavricka: Two great questions, Eric. Thank you. Janet, could you maybe address both questions?

Janet M. J. Hammond: Thank you, Javier; yes, happy to. So firstly, in regard to your question around symptoms in comparison to what happens to the viral load decay, in our overall cohort of patients, and it's a very small cohort of patients, we didn't see much of a correlation between symptom decline and viral load decline. However, when we looked at the patient group who had viral loads in excess of the median, so greater than 5.2 sick logs of viral load, we actually saw a surprisingly good correlation between decline in viral load and declining symptoms.

Janet M. J. Hammond: And so what that would translate to then be that the viral load decline in patients who were treated was associated with a very much more rapid improvement in symptoms and approximately a two-day earlier overall resolution of symptoms. So I think that answers that question. And then, in regard to the pediatric population, yes, we are already in talks with both the EMA and the FDA in regard to our pediatric plan, and those agencies have seen the plan and have provided comments on that.

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Janet M. J. Hammond: And actually, as I mentioned, in our Morning Sky study, we do have plans to start enrolling adolescents into that study because, obviously, they're going to be a really important patient population for that to be treating, particularly as it's taking longer for the vaccines to roll out. So thank you.

Unknown Attendee: Great, thanks for taking the questions.

Operator: Your next question comes from the line of Jonathan Miller with Evercore.

Jonathan Miller: Thanks for taking my question.

Unknown Attendee: First one, on the Big Phase 3 is what percentage of the patients do you expect to be seronegative at baseline, since, as we've seen in other direct-acting antiviral trials, those have been responsible for driving the majority of the benefit. And secondly, we've seen some recent positive results in post-exposure approaches.

Unknown Attendee: double access trials done with monomone antibodies, and we've been one

Unknown Attendee: I'm wondering how that reads through to an oral small molecule approach. Can you do even better, or worse, and remind me what your time is?

Unknown Attendee: Even better, worse, and remind me what your timeline is for initiating some sort of a prophylactic trial, whether pre or post-exposure. Jared?

Janet M. J. Hammond: So with regard to the proportion of patients who are going to be seronegative, I think to some extent my interpretation of the literature to date has been that actually patients who are more immunocompromised and who have higher viral loads tend to be seronegative, and patients who have fewer risk factors and are generally in better shape tend to have lower viral loads and also be seropositive. So I think that for our phase three study, where we're planning to enroll both high and low-risk patients and really roll both populations into a single study, I think it's likely that we will see more patients who tend to be seropositive and seronegative because of the fact that we will have patients who are already low-risk.

Janet M. J. Hammond: and likely to be zero positive, and then the patients who are high risk, I think, as you saw in our hospitalized study, approximately 50% of patients were seropositive or positive. So I'm guessing that that will translate into a higher proportion of patients being seropositive.

Janet M. J. Hammond: But you're right, it's a good question because I think one tends to see a better viral response or it's more easy to see that correlation in patients who start or zero negative just because they have a higher viral load initiating staff. With regard to your question around pre-exposure prophylaxis, I think that there are differences in similarities between what we anticipate seeing. I think we anticipate that pre-exposure prophylaxis ought to deliver similar levels of benefit to what you see with the antibodies.

Janet M. J. Hammond: I think there are both pros and cons to both approaches. The beauty of the approach of a small molecule in that type of setting, obviously, is that access is relatively considerably easier in that you don't need to go and get an injection, and you can initiate therapy much more conveniently. I think the disadvantage to some extent will be that the monoturnal antibodies have a longer duration of effect after a single dose, whereas the prophylaxis with a direct acting antiviral will be dependent on taking the drug, but of course, that means that there is more room for tailoring it and potentially, I suppose, also less likelihood of the genesis of resistance.

Janet M. J. Hammond: So I think we'll have to see how it all evolves and what we learn. But I think that, in general, you know, there are advantages and disadvantages to birth approaches, but we believe that the antiviral efficacy of birth approaches ought to be very similar.

Janet M. J. Hammond: And your plans to initiate this, Your House? I'm sorry, yeah, we plan to initiate

Janet M. J. Hammond: I'm so sorry, yes, we plan to initiate the trial in this second tosses via. Thanks very much. Your next question comes from the line of Tim Lugge with William Blair.

Unknown Attendee: There you guys, this is Lachlan on for Tim. Thanks for taking the questions. First of all, just wanted to clarify that when you said that Morning Sky is enrolling globally, does that include the US? I know that the FDA's kind of delayed that a bit in the past, so I just wanted to check if that's up and running. And second, you've said that you're looking at higher doses. Can you share any details on, you know, what that higher dose is when we might see the first data?

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Unknown Attendee: From that, is that going to be with the Morning Sky readout that he said? It might be late 3 early. for and how much incremental efficacy you might expect to see from that, especially given the bronchio-a-a-lo-a-l-l-l-a-bache that you, the database shared from healthy patients.

John F. Vavricka: I'm going to address the second one, and Chanitz will go over the first one. Look, first we anticipate that there should be a proportional increase in those concentrations. And until we don't have the data, obviously, we cannot make some extrapolations. But from the data that we see and from phase one, which I'm going at higher doses, we believe that there is going to be a substantial drug exposure increase, and hopefully, this should translate into better anti-vinyl efficacy and ultimately, a clinical benefit.

John F. Vavricka: So we are encouraged by the fact that we continue to see the same tolerance and safety. And obviously, we have to expand in a larger court or not. Now, which study will show the results? We have, as Janet has indicated, six studies in parallel, and as soon as the court is completed, we'll share with the street. Janet, do you want to address the first question?

Janet M. J. Hammond: So the first question I think was in regard to Morning Sky and whether it was currently enrolling in the US, and the answer to that is no. We are in discussions with the FDA, but it is currently not enrolling in the US.

Unknown Attendee: Thank you. Just to follow up on that, have they given any guidance as to how much data or how many patients work of data they need to see to allow that to enroll you? Do you have a sense of when that might be able to get up and running?

Janet M. J. Hammond: So I think we don't generally comment on those types of specifics, unfortunately, so I'm not able to answer your question. Go ahead. Thanks. As a reminder to ask a question, you'll need to press star 1 on your telephone to withdraw your question, press the pound key, and your next question comes up. Hi, and I'm showing no more questions at this time.

Operator: Thank you, everybody, for your interest and support and appreciation. So thank you, again, for joining us and continuing to support our chair. Thank you.

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

Operator: Thank you, and so on, and and and so on the Thank you, and so on the Thank you, and so on the Thank you. Thee and so on the Thank you.

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Operator: Thank you. Thank you. Thank you. Thank you, and thank you. Thank you. Thank you. Thank you.