Q3 2021 Atea Pharmaceuticals Inc Earnings Call

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Operator: Good afternoon, ladies and gentlemen. Welcome to the Atea Pharmaceuticals 3rd Quarter 2021 Financial Results Conference Call. At this time, all participants are in a listen-only mode.

Good afternoon, ladies and gentlemen, welcome to the <unk> Pharmaceuticals third quarter 2021 financial results Conference call. At this time, all participants are in a listen only mode.

Operator: I would now like to turn the call over to Jonae Barnes, Senior Vice President of Investor Relations and Corporate Communications at Atea Pharmaceuticals. Please proceed. Thank you, Operator.

The formal remarks, we will open the call up for your questions.

I'd like to turn the call over to Jenny bonds Senior Vice President of Investor Relations and corporate communications at Teva Pharmaceuticals. Please proceed.

Thank you operator, good afternoon, everyone and welcome to Acadia Pharmaceuticals third quarter 2021 financial results Conference call. This afternoon, we issued a press release, which outlines the topics. 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 website.

Jonae R. Barnes: Good afternoon, everyone, and welcome to Atea Pharmaceutical's third quarter 2021 Financial Results Conference call. This afternoon, we issued a press release which outlines the topics 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 investor section of our website at ir.ateafarma.com. With me today from Atea are our Chief Executive Officer and Founder, Dr. John Pierre Samadosi, Chief Development Officer, Dr. Janet Hammond, Chief Financial Officer and Executive Vice President of Legal, Andrea Corcoran, and our Chief Commercial Officer, John Vavricka

IR Dot Italia pharma Dot Com with me today from Matteo <unk>, our Chief Executive Officer, and founder Dr. Johns Here, Simon Doshi, Chief Development Officer, Dr. Janet Hammond, Chief Financial Officer, and Executive Vice President of legal Andrea Corcoran, and our Chief Commercial Officer, John Beck recap they will all be avail.

Jonae R. Barnes: They will all be available for the Q&A portion of today's call. Before we begin the call, as outlined on slide two, I would like to remind you that today's discussion will contain forward-looking statements that involve risk and uncertainties. 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.

For the Q&A portion of today's call before we begin the call as outlined on slide two I would like to remind you that today's discussion will contain forward looking statements that involve risks and uncertainties. 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, Jonae. Good afternoon, everyone, and thank you for joining us today.

Thank you Janet good afternoon, everyone and thank you for joining us today.

John F. Vavricka: In addition to the financial results, we have a number of updates for 8527 to review, including an amendment to the Phase 3 Morning Sky trial protocol and a plan to accelerate its enrollment. Additionally, quantitative infectious virus assay data from the Munson trial, confirming potent and rapid antiviral activity for AT527, and new in vitro data for AT527, demonstrating potent antiviral activity against the major variants of concern or interest, including Delta I will begin on slide 3.

Turning to the financial results, we have a number of updates for 85 to seven to review.

Clothing, and the amendment to the phase III <unk> trial protocol and the plan to accelerate its enrollment.

Quantitative infectious virus assay data from dementia trial.

Confirming potent and rapid antiviral activity of 485 to seven new in vitro data.

Five to seven demonstrating potent antiviral activity against the major variance of concern.

For us including cellphone.

I will begin on slide three.

85 to seven O orally administered product candidate for COVID-19 is a direct acting antiviral agents derived from O peering nucleotide for the platform.

John F. Vavricka: Atea 527, our already administered product candidate for COVID-19, is a direct acting anti-viral agent derived from our purine nucleotide product platform. Atea 527 is designed to protect against disease progression and the development of long-term COVID complications. Given the evolving dynamics of COVID-19, which is becoming endemic, medical intervention and all therapeutics, in particular, will be essential in stemming the tide of this pandemic and future surges. 85 to 7 targets viral RNA polymerase, a highly conserved enzyme critical to viral replication and transcription. Uniquely, AT527 has a mechanism with dual targets.

Five to seven is designed to protect against disease progression and the development of long carbon complications.

Given the evolving dynamics of COVID-19, which is becoming endemic medical intervention and old therapeutics in particular.

It will be essential in stemming the tide of this pandemic and futures soldiers.

85 to seven targets viral RNA polymerase.

Highly conserved enzyme critical to violent vacation insurance scripture.

Uniquely.

85 to seven there's a mechanism was dual targets it is a chain terminator.

John F. Vavricka: It is a chain terminator without introducing new mutations in the virus, and it also inhibits NIRAN, thus providing the potential to create a high barrier to resistance and antiviral activity across variants, as we will share with you in a few minutes, on all slides, in all studies. Atea 527 has been shown to be generally safe and well-tolerated. Of particular note, Atea 527 is not mutagenic, with no reproductive toxicity, and it's non-teratogenic. We expect minimal drug-drug interaction since 8527 is a weak inhibitor of cytochrome P450 3A, and no dose adjustment is expected for co-administration of drugs that are CYP3A substrates, which account for the metabolism of more than 50% of clinically relevant drugs.

Designed to ensure that introducing new mutations and Novartis and it also inhibits in Iran. Thus, providing the potential to create a high barrier to resistance and 90 of all activity across variance, we will share with you in a few minutes.

In all slot in all studies.

Five to seven was shown to be generally safe and well tolerated.

Particularly of note 85 to seven is not mutagenic.

With no reproductive toxicity and its known to Germany.

We extract the minimal drug drug interaction since 85 to seven days, a week and EBITA cyclical people 53, a and no dose adjustment is expected for co administration of drug that the Sip, Sri eight substrate, which account for the metabolism of more than 50%.

Of clinically relevant drugs. So this should make our drug candidate prescribe them.

John F. Vavricka: So this should make our drug candidate prescriber-friendly on slide four. COVID variants of concern continue to create new challenges for treatment and prevention. These variants can also make the execution and evaluation of clinical trial results more challenging because of the impact and differences in viral kinetics as well as clinical symptoms. However, ongoing SARS-CoV-2 genomic surveillance worldwide has improved our ability to rapidly identify such variants. As you can see on this chart, almost 6,000 variants have been sequenced, an outstanding number.

Prescribed with friendly.

On slide four.

Covid variance of concern.

To create new challenges for treatment and prevention.

This variance can also make the execution and evaluation of clinical trial was onto more challenging because of the impact in differences in viral kinetics as well as clinical symptoms.

Ongoing source to genomics civilians worthwhile.

Has improved our ability to rapidly identify such variance.

You can see them discharged on.

Most 6000 variants I've been sequence within of standing number the evolution of the virus will make COVID-19 endemic with the ability to continuous circulating for years to come.

John F. Vavricka: The evolution of the virus will make COVID-19 endemic with the ability to continue circulating for years to come. SARS-CoV-2 variants of interest have been associated with increased transmissibility, Neutralization Resistance, and Disease Severity.

Susko two variance of interest have been associated with increased trends to be stability.

Chinese Asian resistance and disease severity.

The continued spread of Delta.

John F. Vavricka: The continuing spread of Delta has led to a new subtype called AY.4.2 or Delta Plus, which carries additional mutations. Although the original Delta variant remained the most dominant on a global basis, this new mutant now accounts for 14% of infections in the UK, up from less than 4% just early September, and is more likely contributing to the recent surge of the fifth wave of COVID in Western and Eastern Europe and other global areas.

Led to a new year subtype.

Paul a y thoughtful about two or delta plus which carries additional mutation.

Although the original Delta variance remained the most dominant on the global basis. This new medicine now accounts for 14% of infections in the U K.

Up from less than 4% just early September and is more likely contributing to the research. The recent surge of the fifth wave of Covid in western and Eastern Europe, and all the global areas.

John F. Vavricka: Preliminary evidence suggests that Delta Plus spread between 12% and 15% more frequently among household members compared with other Delta viruses and will likely become an important strain, including in the U.S. Moving to slide six. As you know, we have previously shown that AT511, the free base of AT527, is a potent inhibitor of SARS-CoV-2 in vitro. The average EC90 in primary human airway epithelial cells against the original virus isolated in early 2020 was around 0.5 micromole, whereas a five-fold assay, approximately assay to assay variability, as you can see in this slide. We recently evaluated our drug candidates against the major variants of concern or interest, including Alpha, Gamma, Epsilon, and more recently Delta, consistent with its dual mechanism of action. AT511.

Preliminary evidence suggests the delta plus spreads between 12 and 15% more frequently.

Household members compared with all the downtown viruses and will likely become unimportant strain, including in the U S.

Moving to slide six.

As you know we have previously shown that 80 511, the free base of 85 to seven years.

As a potent inhibitor of Sars cov two in vitro.

Average <unk> 90 in primary human airway epithelial cells against the original revised isolated in early 2020 was around <unk> five micro mall with a fivefold, let's say approximately.

St USA variability as you can see in the slides.

We recently evaluated our drug candidate against the major variance of concern or interest, including Alpha Gamma Epsilon and more recently Delta.

System is its dual mechanism of faction.

511 maintained its potency against all the variance tested including downtown we.

We believe that these data confirm the key mechanistic advantage for this drug candidate, which targets the highly conserved vital when they put them always in fact, we have analyzed over 3 million Sars cov two sequences the positive in the database today and.

John F. Vavricka: maintain its potency against all the variants tested, including Delta. We believe that this data confirms the key mechanistic advantage of this direct candidate, which targets the highly conserved viral RNA polymerase. In fact, we have analyzed over three million SARS-CoV-2 sequences deposited in the database today and found that less than 0.01% have mutations near the active site of the SARS-CoV-2 polymerase. With that, I will now turn the call over to Janet for a more detailed review of our clinical progress.

Found that less than 0.0% to 1%.

As a mutation near the active side of this.

<unk> to 'twenty mice.

With that I will now turn the call over to Janet for a more detailed review of our clinical programs.

Thank you Sam Kemp.

Beginning with slide <unk>.

As you can see on this slide.

Clinical program includes six.

Hi.

We're running in parallel.

We are leveraging lessons learned.

From each other.

Paulson.

Program in real time.

Two key updates on this trial can you just financing the 85 to seven 1100 milligram B I D D hospitalized.

Janet M. J. Hammond: Beginning with slide A. As you can see on this slide, our robust clinical program includes six studies of 85 to 7, which are running in parallel. We are leveraging lessons learned from each of these studies to better serve our patients and updating our program in real time. There are two key updates on this slide, which include advancing the AT527 1100mg BID dose in the hospitalized study, and we expect results from the next cohort in the first half of next year.

And we expect results from the next cohort.

Yeah.

In addition to our menu.

The phase III Morningstar, all trial protocol within your primary endpoint defined patient population and can increase dosage.

We have a plan to accelerate enrollment completion.

Have you in the morning, Apple towards the end of my presentation.

Turning to slide nine.

As COVID-19 has continued to fall.

The way to quantify the bonds after.

After considerable effort.

And optimized in pictures.

Now available to quantify the Apple infectious virus in addition to the RT Pcr.

Janet M. J. Hammond: In addition, we are amending the Phase 3 MorningSky trial protocol with a new primary endpoint, a refined patient population, and an increased dosage, and we have a plan to accelerate enrollment completion. I will review the MorningSky updates towards the end of my presentation.

Which measures all forms of our army tank.

That's helpful.

Just a further just from intact reputation bar from.

Non baffles or Austin please.

Perfect.

This is important because it's more often.

Cost of a direct acting antiviral ongoing infection.

Our next review the new voluntary move outs or any suffice to separate from the move from trial roughly half the phones are using this influx of borrowers thankful.

All of our client on Saipem.

Janet M. J. Hammond: As COVID-19 has continued to evolve, so have the ways to quantify the virus. After considerable effort, an optimized infectious virus assay is now available to quantify viable infectious virus in addition to the RT-PCR assay, which measures all forms of viral RNA obtained from a sample, regardless of whether it is from intact replicating virus, or from non-viable virus, or simply viral fragments. This difference is important because it should be a more accurate assessment of the impact of a direct acting antiviral on the ongoing infection.

Methodology.

And your slides the highly sensitive thoughts Casey to lifestyle offering.

Measuring why sorry.

Nasal pharyngeal swab samples from patients has been very challenging.

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As an important advance.

Please proceed quantitative data from a related party. It was reported during the development of ammonia terrible.

In order to request.

And Giovanni first of all I've got confidence that using bye bye.

In collaboration with our partner Bunge has developed and optimized highly sensitive and quantitative infectious virus.

Yeah.

As illustrated in the cloud.

Janet M. J. Hammond: I will next review the new viral load results for AAC527 from the Moonstone trial that we have obtained by using this infectious virus app. Assigned Client on Site-10, Our methodology is quantitative and utilizes the highly sensitive SARS-CoV-2 live virus. Measuring live virus in nasopharyngeal swab samples from patients has been very challenging for this evolving field, but it is an important advance. Previously, qualitative data from a related type of athlete were reported during the development of monocerval.

Modified <unk> Lange Buckingham.

That's just Sars COVID-19, two whether or not Sanofi cherokee's Andrews with nasopharyngeal samples.

We can determine the classroom wow.

There's multiple slow August southward.

<unk> can be too specific.

This newly optimized also has three key at Boston.

Firstly as qualified infectious viral.

Eliminating the possibility of non infectious virus awhile fragments biotic keep PCI pieces or portions.

<unk> has developed a monitor their reported infectious virus afterwards, just quantitatively any positive or negative.

Janet M. J. Hammond: In order to assess more specifically the antiviral effect of our drug candidate by using live virus, our CRO, in collaboration with our partner Roche, has developed an optimized, highly sensitive, and quantitative infectious virus, Pfizer-Ace. As illustrated in this slide, a modified cell line with enhanced susceptibility to SARS-CoV-2 was inoculated with clearly diluted nasal pharyngeal samples, so that we can determine the title as After six days of incubation, positively infected cells were detected by SARS-CoV-2-specific immunostaining.

Actual bottle okay.

Thank you Kate this is very accurate.

It's a highly sensitive.

A quick question.

It was equivalent to approximately <unk> 10, with such as Bos cost postponed a little looser.

Please note that the analysis includes the approximately 72, 1% of all patients and lymphoma cohorts, Andy who have positive both on culture.

On slide 11.

Our portal and such.

Halloween is on study.

We'll see that some careful theme in the air.

The whole population, including both high and low risk patients with the majority being positive.

H five to seven at 1100 milligrams B I D trade to patients.

Janet M. J. Hammond: This newly optimized assay has three key advantages. Firstly, it quantifies the infectious virus, thus eliminating the possibility of non-infectious virus or viral fragments by RT-qPCR as previously reported. Earlier assays developed with monopilia reported an infectious virus assay which was qualitative, only positive or negative, with no actual viral characters defined. Secondly, this is very accurate. And thirdly, it is highly sensitive.

Strange of Rockford and taken production the volunteers.

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Placebo Apple tree planting.

Well.

We're able to see if I can talk with patients watch houses with underlying health conditions and these results reinforced exploratory analyses in the same population with RT PCR Nanchang and the phase two study in hospitalized patients.

In total <unk>.

So if you treat a patient administered 1100 milligram B I D.

A robust founder introduction of pipeline for logs at day three.

These data also.

Janet M. J. Hammond: The level of quantitation of the assay is equivalent to approximately 10 infectious virus particles per milliliter. Please note that the analysis includes approximately 71% of all patients in Moonsong Cohorts A and B who had positive baseline calcium. [inaudible] Today we are reporting infectious virus data from the Moonsong study. You'll see that in Cohort B, in the overall population, including both high and low risk patients, with the majority being seropositive, 8527 at 1100 mg BID-treated patients demonstrated a rapid and potent reduction in the viral load of half-log versus placebo at day 3.

I suggest that dose response between cohorts.

Carefully.

Moving to slide 13.

I have just outlined is additional data from the phase <unk> trial support the rapid and potent antiviral effect of 85 to seven.

As measured by quantitative hardly census of Intouch stars docile, which detect plaza capable of replication.

Leveraging the lessons from Mervin song and as outlined in slide 14, as well as other research results Yeah listing amendments the global Phase III Morningstar trial.

Good morning, Scott is a randomized double blind multicenter placebo controlled phase II trials evaluating the antiviral activity.

I'm pharmacokinetics 85 to seven and approximately 1600 patients randomized one to one to receive 85 to seven 1100 milligrams twice a day or placebo.

Janet M. J. Hammond: We are able to see a treatment effect in the subgroup of patients who are at high risk with underlying health conditions, and these results reinforce the exploratory analysis in the same population with RT-PCR in Moonsong and the Phase II study in hospitalized patients. In Cohort B, the acidly treated patient administered 1100 mg BID had a robust viral load reduction of 0.9 of a log at day 3. These data also show a suggested dose response between cohort A and cohort B. Moving to slide 13.

We together with Roche plans to leverage the existing operational cable infrastructure from the morning squad clinical trial site.

And expand its footprint with approximately 300 sites and use Yelp Murphy.

We expect to report the data from this trial in second half 'twenty to 'twenty two.

Amendments to our morning Sky study to define them.

Changing the trials primary endpoint to COVID-19 related hospitalization.

All cause mortality.

Previous primary endpoint of time to alleviation or improvement as COVID-19 symptom will become a secondary endpoint.

Janet M. J. Hammond: As I have just outlined, these additional data from the Phase II Moonsong trial support the rapid and potent antiviral effect of AC527 as measured by a quantitative, highly sensitive infectious virus assay that detects live viruses capable of replication. Leveraging the lessons from Moonsong and, as outlined in slide 14, as well as other recent results, we are submitting amendments to the Global Phase 3 MorningSky trial. MorningSky is a randomized, double-blind, multi-center, placebo-controlled, phase 3 trial evaluating the antiviral activity, safety, and pharmacokinetics of AT527 in approximately 1,600 patients randomized one-to-one to receive AT527 1,100 milligrams twice a day or placebo.

Refining the patient population to include Andexanet high risk individuals.

And lastly, increasing the dose of 85 to seven to 1100 milligrams twice daily from 550 milligrams B I D.

Patients enrolled in morning Sky have the option to be enrolled in later spring.

Six month long term follow on study conducted in collaboration with Roche to value with lung cancer in patients who received 85 to seven in comparison to placebo <unk> morning, Scott.

Let's now turn to <unk> 75 to a program for the treatment and prophylaxis of dengue fever on slide 16.

I don't know what the CRB initiatives is a randomized double blind placebo controlled single and multiple ascending dose phase one study to evaluate the safety Tolerability and pharmacokinetics with HSR from five two in healthy subjects.

We have completed one of the study the single ascending dose clinical and didn't talk too.

First two cohorts are complete and the last critical to the long game.

Janet M. J. Hammond: We, together with Roche, plan to leverage the existing operational global infrastructure from the MorningSky clinical trial site and Expanded Footprint with approximately 300 sites in New Geography. We expect to report data from this trial in the second half of 2022. Amendments to our Morning Sky study include the following.

We expect completion of the study by year end.

During the first half of 2022.

We expect to initiate a phase two study of 80 752 for the treatment of <unk> in Asia and South America.

In this trial, we will enroll at all with a fever graces in 38 degrees within 48 hours of probable dengue infection and positive results from an S. One antigen test until Aki Pcr assay.

The primary endpoint will be change in viral loads from baseline.

We look forward to keeping you apprised of our progress in this important study next year.

Janet M. J. Hammond: Changing the trial's primary endpoint to COVID-19-related hospitalization will all cause mortality. The previous primary endpoint of time to alleviation or improvement of COVID-19 symptoms will become a secondary endpoint, refining the patient population to include only unvaccinated high-risk individuals. And lastly, increasing the dose of AT527 to 1100 mg twice daily from 550 mg BID. Patients enrolled in MorningSky have the option to be enrolled in LaterSpring, a six-month long-term follow-on study conducted in collaboration with Roche to evaluate long-term COVID in patients who received AT57 in comparison to placebo in MorningSky.

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

Thank you Janet.

What's your name mentioned in her introductory remarks. This afternoon, we issued a press release containing our financial results for the third quarter of 2021.

Mid of operations and the balance sheet or on slides 18 and 19.

For the third quarter 2021, and the increase in R&D expenses in comparison to the third quarter of 2020 was principally driven by an increase in external clinical development and manufacturing expenses incurred primarily in conjunction with the advancement of 85 to seven for the treatment of COVID-19 and to a lesser extent.

It keeps them in part two which is being developed for dengue fever. These expenses include our share of cost incurred by Bruce and increases in internal 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 in 2021 and consists principally and an increase in payroll and personnel related expenses.

Janet M. J. Hammond: Let's now turn to HE752, our program for the treatment of prophylaxis of dengue fever on slide 16. Earlier this year, we initiated a randomized, double-blind, placebo-controlled, single, and multiple ascending dose phase one study to evaluate the safety, tolerability, and pharmacokinetics of A2752 in healthy subjects. We have completed part one of the study, the single ascending dose cohort, and in part two, the first two cohorts are complete, and the last cohort is ongoing.

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

At September 32021, cash and cash equivalents were 839 7 million.

This includes the $50 million development milestone the company received in July under our license agreement with Roche.

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

Thank you Andre as Janet outlined the political changes, we are making through the phase III morning, Scott study maximize our ability to demonstrate positive clinical outcome.

Janet M. J. Hammond: We expect the conclusion of this study by year end. During the first half of 2022, we expect to initiate our Phase 2 study of 87.5.2 for the treatment of dengue fever in Asia and South America. In this trial, we will enroll adults with a fever greater than 38 degrees within 48 hours of probable dengue infection and a positive result on the NS1 antigen test and 4RT-PCR assay.

The updated inclusion criteria dosing regimen and primary endpoint should allow execution of a more focused and de risked trial.

Importantly, the encouraging infectious virus data, we have disclosed today give us further confidence in 85 to seven and rapid and potent antiviral activity against COVID-19, which is critical to stopping disease progression in transmission.

Continue to be very excited by the opportunity to change the quarter COVID-19 dengue fever.

D C and although viral infections. This is an exciting time to be.

Andrea J. Corcoran: The primary endpoint will be changed to viral loads from baseline. We look forward to keeping you apprised of our progress in this important study next year. With that, I will now turn the call over to Andrea for a review of the financials. Thank you, Janet. As Jonae mentioned in her introductory remarks, this afternoon, we issued a press release containing our financial results for the third quarter of 2021. The statement of operations and the balance sheet are on slides 18 and 19.

Bringing forth, what we believe to be groundbreaking technologies and we look forward to updating you on our progress.

As always we thank you for your continued support as we build that into a global leader in the discovery development and commercialization of all therapies that address the unmet medical needs of patients with life threatening viral diseases.

With that operator, we will now open the call up to your questions.

Alright, so 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 again that is star one on your telephone please standby will be compared the Q&A roster.

First question comes from the line of Eric Joseph from Jpmorgan. Your line is now open.

Andrea J. Corcoran: For the third quarter of 2021, the increase in R&D expenses in comparison to the third 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 is being developed for dengue fever. These expenses include our share of costs incurred by Roche and increases in internal spending, mostly due to an increase in personnel-related expenses.

Hi, Good afternoon. This is Hannah on for Eric Thanks for taking the questions just a few from us.

So first just wanted to get your thoughts on the feasibility of conducting the phase III trial, where we have either a pill counts COVID-19 and monitor their acceptable how confident are you in the state of the timelines that you've given and then also with the recently.

Reported when does it hit your outpatient trial pine tree, which showed a meaningful effect in hospitalization or death, despite minimal or really no effect on viral load just wanted to get your take on this dataset and then from a theoretical perspective, what other than viral load reduction do you think might translate to good effect on clinical outcomes. Thank you.

Sure Janet.

To address those questions. Please.

Thank you Sir.

Got to proceed ability of conducting the study.

We believe that I'm still feasible.

I think it's unfortunate.

Andrea J. Corcoran: The increase in general and administrative expenses was primarily due to the expansion of our organization in 2021 and consists principally of an increase in payroll and personnel-related expenses. I am pleased to report that we ended the third quarter with a strong balance sheet to support our clinical development program. As of September 30, 2021, cash and cash equivalents were $839.7 million. This includes the $50 million development milestone the company received in July under our license agreement with Roche. I'll now turn the call back over to Jean-Pierre for his closing remarks.

But I.

I think that's being rolled out across the work.

While impressive in many places is lagging and many others and I think that Unfortunately, this provides an opportunity for them really.

Many high risk patients.

And the disease, we have an extensive.

<unk> or <unk>.

Ready and plan to have a step further.

Footprint as we move forward as I mentioned, we'll have more than 300.

Or thereabouts.

And so we believe that.

So to be able to be.

Enrolled and completed in the timeframe that you suggested.

And then with regard to room does that I wasn't sure that I understood. Your question I think Scott Walker and desert area.

Sure very elegantly and in a large study or Randy that there was no correlation between browsers and clinical that's correct and I think that's perfectly that is true.

John F. Vavricka: Thank you, Andrea. As Janet outlined, the protocol changes we are making to the Phase 3 MorningSky study maximize our ability to demonstrate a positive clinical outcome. The updated inclusion criteria, dosing regimen, and primary endpoint should allow execution of a more focused and de-risk trial. Importantly, the encouraging infectious virus data we have disclosed today give us further confidence in 85 to 7's rapid and potent antiviral activity against COVID-19, which is critical to stopping disease progression and transmission.

General for the direct acting antivirals, particularly when measured by oxy.

Oxy, PCR and I think I'm really kind of work with them.

We have attempted shirt. Okay is Randy that in addition to RT, PCR, which seems to be a rather blunt tool and I think as.

As such the.

Live virus assay and that we have reported on seems to be somewhat more able to discriminate between viral fragments and nonviable darice, an actual live virus and I think we're actually sharing.

Nike and even the suggestion of a dose response in Walker seeing them.

Separately clinical endpoints are really worried at all about ultimately I forgot this little karabakhis sensitive patients gets better and if we can prevent hospitalization and find some targets endpoint, which was able to help them support and.

John F. Vavricka: We continue to be very excited by the opportunity Atea has to change the course of COVID-19. Thank you for Hepatitis C and all of our infections. This is an exciting time to be bringing forth what we believe to be groundbreaking technologies, and we look forward to updating you on our progress. As always, we thank you for your continued support as we build Atea into a global leader in the discovery, development, and commercialization of oral therapies that address the unmet medical needs of patients with life-threatening bowel disease. With that, Operator, we will now open the call to your questions.

Ultimately be a useful target endpoint that would be great, but I think the room desert greater actually are supportive of the field in general than what others are experiencing as well as ourselves.

Okay, Great. That's helpful. Thanks for taking the questions.

Thanks, Simona Q is Jonathan Miller from Evercore ISI. Your line is now open.

Thanks, so much for taking the questions guys.

I have a couple of maybe more detailed ones on some of the data we released today.

You mentioned that your phase II cohort is majority of tier a positive I think you said 71 per cent seropositive baseline how different are the results there between sera positive and negative patients at baseline for one.

And then secondly.

Sort of falling on the last question. It seems like the majority of the patients on the one one gram arm in phase two were high risk.

Operator: Alright, so as a reminder, to ask a question, you will need to press star 1 on your telephone. To resolve your question, press the pound key.

And turn it back out obviously you might had on large scale, but is it fair to say that the viral load impact in low risk patients is really pretty modest and then following on that prior question.

Operator: Press the pound key. Again, that is star 1 on your telephone.

Operator: Please stand by while we compile the Q&A roster. The first question comes from the line of Eric Joseph from J.P. Morgan. The line is now open. Hi.

If you think that there's not a good read through from viral load to clinical efficacy do you expect that direct acting antivirals, maybe broadly will have a meaningful clinical impact in low risk patients.

Hannah: Hi, good afternoon; this is Hannah on behalf of Eric. Thanks for taking the questions; just a few from us. So first, just wanted to get your thoughts on the feasibility of conducting the phase three trial where we have the Pfizer pill, PaxLivid, and MonocularVir accessible. How confident are you in the stated timelines that you've given? and then also with the recently reported remdesivir outpatient trial Pine Tree, which showed a meaningful effect in hospitalization or death, despite a minimal, or really no effect on viral load. I just wanted to get your take on this data set.

And I guess I'll pause there to allow middle East Africa.

Janet.

Sure. Thanks, John.

Firstly in regard to your question around the share of positivity, you see pockets of who is actually very high and.

Perhaps not surprisingly increased I think.

In total the risks are.

And some of the final until obviously, there's some carryover.

Preferably in critical B.

87% of treated patients with <unk> positive and I think is centered in the placebo group, So really high number and I think that the plant what youre able to see.

Hannah: And then from a theoretical perspective, what other than viral load reduction do you think might translate to an effect on clinical outcomes? Thank you. So, with regard to the feasibility of conducting the study, we believe that it's still feasible, and in some ways, I think it's unfortunate that it is, but I think vaccine rollout across the world, while impressive in many places, is lagging in many others, and I think that, unfortunately, this provides an opportunity for many high-risk patients still to be susceptible to the disease. We have an extensive footprint already and plan to have a still further extensive footprint as we move forward.

Has it gone six months I think in the high risk patients than in the other ones, but I think essentially to work with being and I think perhaps answer.

So second question two around the <unk> impact from the low risk patients.

Kelly if you wonder risks are able to kill the virus.

Effectively yourself without the need for a direct acting antiviral.

But I think if you're able to prevent hospitalization and I think as others have demonstrated preventing hospitalizations and death in harvest cushion.

Believes after having a similar effect, although it's harder to measure and patients who are.

Aetna or modest Chris for those types of outcomes, but nevertheless.

And something that you'll you'll probably shortening the duration of symptoms and this is something that had been hurting too demonstrated in our phase III trial, but it seems that these harder endpoints are suddenly easier to document and I think that that's frankly.

John F. Vavricka: As I mentioned, we'll have more than 300 sites or thereabouts in the trial and so we believe that study ought to be able to be enrolled and completed in the timeframe that we suggested. And then with regard to remdesivir, I wasn't completely sure that I understood your question. I think that what remdesivir showed very elegantly and in a large study was really that there was no correlation between viral load and clinical effect and I think that probably that is true in general for the direct acting antivirals, particularly when measured by RT-PCR and I think really some of what we have attempted to show today is really that in addition to RT-PCR, which seems to be a rather blunt tool and I think is recognized as such, the live virus assay that we have reported on seems to be somewhat more able to discriminate between viral fragments and non-viable virus and actual live virus and I think we're actually showing quite nicely even a suggestion of a dose response in what we're seeing there.

Pilot going in the direction that could be off with Morningstar, but I think critical showing the types of benefits of high risk patients.

We need to find the tools in which we demonstrate that in order to protect high risk patients or Kenny also showing benefits and nervous patients, albeit borrow there and particularly by RT PCR isn't the cause.

Perfect measure, but I think I think you can see that there are reductions in viral load across the board and I think just the higher risk patients Cliff surprisingly also do tend to start off with handlers and Kelly you need to have a.

They get a delta to be able to demonstrate something so I think I think it all.

And tells US tells the same story.

I hope that answered the question.

Yes, somewhat and then I guess one final one how are you defining high risk in the new criteria.

So I think it's I think the definition is pretty standard.

In terms of patient.

Patients being elderly.

It'd be diabetic.

Immuno suppressed.

And.

Thank you.

And also potentially asthmatic patients with underlying renal disease.

Underlying tumors and social.

John F. Vavricka: Certainly, clinical endpoints are really what it's all about ultimately, and that's what we all care about, whether the patient gets better, and if we can prevent hospitalization and find some surrogate endpoint which is able to help support that and, ultimately, be a useful target, and that would be great, but I think the Remdesivir data actually are supportive of the field in general and what others are experiencing as well as ourselves. Okay, great. That's helpful. Thank you. Next one on the queue is Jonathan Miller from Evercore ISI. Your line is now open.

Potentially.

And have to come from their cardiovascular disease.

Okay. Thanks, very much good luck.

Uh-huh serve for the next question, we do have Tim Lugo from William Blair. Your line is now open.

Thanks for the question and the additional data.

I'd like maybe a broader.

Question on given.

Given the recent impressive protease inhibitor data I'd just love to hear your updated thoughts around targeted deal in April and raised directly versus the protocols.

No.

<unk>.

He was previously were thinking for correlations between HCV and HIV and other more chronic diseases would suggest we are in Oklahoma as well.

Targets for minimizing resistance, but is that still the case.

Can we can we really extrapolate those diseases.

Those two and COVID-19.

Well look first we won't come really all progress.

In developing treatments.

The multi pronged approach.

Two.

To combat COVID-19, pandemic and as there is several vaccines.

Jonathan Miller: Thanks so much for taking the questions, guys.

Jonathan Miller: We have a couple of maybe more detailed questions on some of the data you released today. You mentioned that your Phase II cohort is...

We believe that multiple treatment options would be needed.

So.

Regarding I don't think that.

One targets.

Jonathan Miller: I think you said 71% seropositive at baseline. How different are the results there between seropositive and negative patients at baseline, for example? Then secondly, and sort of following on from the last question, it seems like the majority of the patients on the 1.1 gram arm in phase two were high risk. And just trying to back out, obviously it's tough to do with my head on a long scale, but it's fair to say that the viral load impact in low-risk patients is really pretty modest.

Going to be better than than the other one.

You have seen.

<unk> just mentioned about.

The women's as you've been patient.

Patients. Unfortunately, the drug can be given only IV and obviously, we know their limitations.

I think we have not seen.

From from Faiza, all the detail analysis of the data.

Looking about viral load talking about.

Central of emergence of resistance.

And what.

What I believe are what we believe is that it.

Jonathan Miller: And then following on that prior question, If you think that there is not a good read-through from viral load to clinical efficacy, do you expect that direct-acting antivirals, maybe broadly, will have a meaningful clinical impact in low-risk patients?

It's going to be a very different.

I would say.

Situation.

Real World.

Then in clinical trials with.

For the Ace inhibitors.

Potentially using immuno compromised patients are used.

So.

With.

Maybe.

Issues.

On.

Taking all these.

The doses.

Right timing and so.

Jonathan Miller: And I'll, I guess I'll pause there. There is a lot of fiddly stuff there.

We have to see lets not forget that Amy drug any antiviral drug Oh.

John F. Vavricka: Yes, seropositivity was actually very high and perhaps not surprisingly increased, I think, as the study went on, although we're still awaiting some of the final serology data from Cohort A. But certainly, in Cohort B, 87% of the treated patients were seropositive, and I think 80% in the placebo group, so really high numbers.

It was one point mutation.

We're very likely lead to resistance when Tommy flu was launched in 2008 2009, there was absolute team, though is just it all just one year later.

It was the majority of the.

Through a strange way resistance to whoever system Tommy flu, so I don't want to to picture it.

Future negative.

Picture on protease inhibitors, because I think we have to be we can celebrate today, we should celebrate.

John F. Vavricka: And I think that does blunt what you're able to see. Perhaps it blunts it less, I think, in the high-risk patients than in the other ones. But I think essentially what we're seeing, and I think it perhaps answers some of your second question, too, around the viral load impact in the low-risk patients. I think clearly, if you're low risk, you're able to clear the virus perhaps more effectively yourself without the need for a direct acting antiviral.

But in the same time, we need to.

See the reality for the future as Janet indicated.

We are going to have an endemic situation there is going to be new strains and.

And I believe that.

I would not be surprised that we are going to talk about combination therapies as you know Tim.

With a potentially.

The combination of two different classes.

And Pi and Nick has been shown in the past to be.

A very interesting combination so I think what we have.

Over the last.

John F. Vavricka: But I think if you're able to prevent hospitalizations, and I think, as others have demonstrated, preventing hospitalizations and death in high-risk patients, you have to believe that you're having a similar effect, although it's harder to measure, in patients who are at lower or more modest risk for those types of outcomes. But nevertheless, I'm certain that you're probably shortening the duration of symptoms. And this is something that we have been hoping to demonstrate in our phase three trial.

12 to 18 months is what we know today it may be different than six months and surely in 12 months to come so I would be I would be cautious there.

Okay.

Understood and.

I agree I think we're all looking towards the first combination, but that's going to be incredibly interesting.

But I guess generally when we look across the oral trials and even run disappear as well.

The number of enrolled in the other trials have just been so much higher I know Lin song.

Hook, a while to get underway.

Comments on <unk>.

Now you know Morningstar will be different in terms of patient enrollment and really pushing patient enrollment.

Or is it did take a long time to get those patients.

Absolutely right.

John F. Vavricka: But it seems that these harder endpoints are certainly easier to document. And I think that points us to why we're going in the direction that we are with MorningSky. But I think that if you're showing those types of benefits in high-risk patients, we need to refine the tools in which we demonstrate that in order to protect high-risk patients, you're clearly also showing benefits in lower-risk patients, albeit viral load, and particularly RT-PCR, isn't the perfect measure.

Uh huh.

Aware of it Janet.

Sure basically what.

We are putting in place and though we foresee to accelerate that.

In the morning Sky enrollment after we will have.

Basically file and and finalized the amendment with the regulatory authorities.

Sure I think we have we have increased the sample size somewhat.

We certainly have I think really.

<unk> doubled down on the geographical footprint, and particularly looking as Erez program Nike to be able to enroll patients who are vaccinated.

John F. Vavricka: But I think you can see that there are reductions in viral load across the board. I think just the higher risk patients, perhaps less surprisingly, also tend to start off with higher loads. And clearly, you need to have a bigger delta to be able to demonstrate something. So I think it all tells the same story quite cohesively. I hope that answers the question.

And I think I think with that footprint and also I think we see them.

The potential for conducting an interim analysis and cheerful submit it to what others have been able to do we believe that we should be able to meet the timelines that we are committing to.

John F. Vavricka: Yes, somewhat. And then I guess one final one: how are you defining high risk in the new criteria?

And and.

Confidence that this is this is.

John F. Vavricka: So I think it's, I think the definition is pretty standard in terms of patients being elderly, obese, diabetic, immunosuppressed, and I think also potentially asthmatic patients with underlying renal disease, underlying tumors, and so forth. And hypertension, and hypertension here, cardiovascular disease.

Which is still possible, we realized that the window is going to carry as more people become back to nature and also our therapies.

Become more accessible but.

Well, we're certainly committed to doing the same.

Really believes that we can.

Sure Scott.

John F. Vavricka: Thanks very much, guys. All right.

Understood.

Maybe another one just how many patients have been enrolled in Morningstar.

Operator: So for the next question, we do have...

When you filed a protocol amendments.

Operator: We do have Tim Lugo from William Blair. The line is now open.

And.

If I recall I think the higher dose had a bit of a noise.

Timothy Francis Lugo: Thanks for the question and the additional data. I'd like maybe a broader question on, you know, given the recent impressive protease inhibitor data, I'd just love to hear your updated thoughts on targeting the RNA polymerase directly versus the protease. You know, we, I guess, previously thought the correlations between HCV and HIV and other more chronic diseases would suggest RNA polymerase was the correct target for, you know, minimizing resistance, but is that still the case, and can we kind of, can we really extrapolate those diseases to SARS-CoV-2 and COVID-19?

Signal are you going to be around allowing anti emetic good morning, Scott.

And I.

I guess also can you maybe give us some more details on this additional cohort for Moon songs there will be the expected early next year.

Okay.

Please proceed with regard to the number of patients is not something that is clear.

Yes.

Secondly, with regard to the use of antiemetic.

We are.

Going to <unk>.

Take positions on does the fact that there has been some Gi signal, we don't believe that it's.

Taken any significant one scenario, but it's certainly something that we are actively managing and also assessing studies to assess how best to address it in terms of potential.

John F. Vavricka: Well, look, first of all, we welcome really all progress in developing treatments as part of a multi-pronged approach to combat the COVID-19 pandemic. And as there are several vaccines, we believe that multiple treatment options will be needed. So in that regard, I don't think that one target is going to be better than the other one.

Potential food effects and protecting patients from seeding these symptoms and something that we're actively working on.

Go into actually believe yes, exactly fully understand the significance of it.

As there were some peculiarities with scripts and patients.

The adverse events were experienced.

In particular all of the adverse events.

John F. Vavricka: You have seen the data I just mentioned about remdesivir in the outpatient setting. Unfortunately, the drug can be given only by IV, and obviously, we know the limitations. I think we have not seen from Pfizer all the detailed analysis of the data, talking about viral load, and talking about the potential for the emergence of resistance. And what I believe, what we believe, is that it's going to be a very different situation in the real world than in clinical trials with protease inhibitors potentially used in immunocompromised patients, used in, so, with maybe issues with taking all the doses at the right time.

Resulted in discontinuation or came from same site.

It's somewhat unusual answer.

We're still trying to really understand bathroom warehouse conference to managers, we will allow the use of guns genetics and make those available but on the other hand, we don't want to encourage and here.

Allow people to believe that this is something that they're going to experience because it is something which I think is susceptible to some auto suggestion.

Quite a tricky one to manager and Brad we're actively thinking our way through that and then and then lastly in regards to your question around noon.

Rental Carrington wrote and he saw the cohorts and then some at least at the moment.

Okay.

For all the granularity and.

John F. Vavricka: And so we have to see, let's not forget that any drug, any anti-rural drug with one point mutation will very likely lead to resistance. When Tamiflu was launched in 2008-2009, there was absolutely no resistance at all. Just one year later, the majority of the flu strains were resistant to Tamiflu. So I don't want to paint a future negative picture of protease inhibitors. But I think we have to be; we can celebrate today; we should celebrate, but at the same time, we need to see the reality for the future.

So all the interest that's the block. Thank you Tim Thank you.

Next one on the Q is it rollout Rwanda release from SBB Leerink. Your line is now open.

Alright, Thanks for taking the question a couple regarding morning Sky I was curious in your protocol Amendment plan would you, possibly explore going for an even shorter time period than five days in symptom onset as I believe I think pfizer's in turn had a less than three days of symptom onset or less.

John.

So Richard Shannon with breaking to allow patients.

John F. Vavricka: As Janet indicated, we are going to have an endemic situation, there will be new strains, and I believe that I would not be surprised that we are going to talk about combination therapies, as you know, Tim, with potentially the combination of two different classes, PI and NIC have been shown in the past to be a very interesting combination. So I think what we have learned over the last 12 to 18 months is that what we know today may be different in 6 months and, certainly, in 12 months to come. So I would be cautious.

Who have had symptoms for five days on net I think we will certainly be trying to ascertain whether that symptom duration for churches imagine because correct me analyzed.

Shorter duration and see them.

With regard has an impact there was a small impact I think in the study, but it actually was.

Rising before George I mean, I think it was 87 versus 89%.

I'm sure. She is obviously best of luck.

I don't think it would make as much of a difference as I was expressing.

Okay makes sense.

John F. Vavricka: Okay, that's understood, and I agree. I think we're all looking towards the first combination that's going to be incredibly interesting. But I guess generally, when we look across the oral trials and even remdesivir as well, the patient numbers that have been rolled out in the other trials have just been so much higher. I know Moonsong took a while to get underway. Maybe comment on how, you know, Morning Sky will be different in terms of patient enrollment and really pushing patient enrollment because it did take a long time to get those patients.

And I was also curious in the remarks it sounded like you will run the new morning Sky protocol by the FDA. So does that mean that you're taking steps toward opening some trial sites in the U S or could you just given us an update on where that stands right now that'd be great.

Alright, I can give you.

Broad update which is that we continue to engage with the FDA and we will be sharing with them the protocol and we have.

And positive dialogue and we do hope that we will be enrolling patients in the U S. In the study, but I think that's about right.

Okay, Sir thanks.

Thanks.

And there are no further question on a Q O and I will turn the call over her back to the presenters.

John F. Vavricka: You're absolutely right, Tim. We are very aware of it. Janet, would you share basically what we are putting in place, and now we foresee accelerating the Morning Sky enrollment after we have basically filed and finalized the amendments with the regulatory authority?

So again, thank you very much for.

Participation in that I would like to thank everyone and thank you again goodnight.

Yeah.

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

Janet M. J. Hammond: So I think we have, we have increased the sample size somewhat. But we certainly have, I think, really doubled down on the geographical footprint, particularly looking at areas where we're likely to be able to enroll patients who are unvaccinated. And I think, I think with that footprint, and also I think with the potential for conducting an interim analysis, and so forth, similar to what others have been able to do, we believe that we should be able to meet the timelines that we are committing to, and we are confident that this is something that is still possible. We realize that the window is going to close as more people become vaccinated and also as therapies become more accessible. But we are certainly committed to doing this and really believe that we can.

[music].

Janet M. J. Hammond: Okay, that's understood. And maybe another question, well, I guess, how many patients had been enrolled in MorningSky by the time you filed your protocol amendment? And, you know, if I recall correctly, I think the higher dose had a bit of a nausea signal. Are you going to be allowing anti-emetics in Morning Sky? And I'd also like to ask you maybe to give us some more details on this additional cohort from Moonsong that we'll be expecting early next year?

Janet M. J. Hammond: So firstly, with regard to the number of patients, it's not something that we've disclosed. Secondly, with regard to the use of antiemetics, we are going to educate physicians on the fact that there have been some GI side effects. We don't believe that it's a particularly significant one at the moment, but it's certainly something that we are actively managing and also setting up studies to assess how best to address it in terms of potential food effects and protecting patients from experiencing these symptoms, and something that we're actively working on.

[music].

Janet M. J. Hammond: But we don't actually believe yet that we fully understand the significance of it, as there were some peculiarities with the patients where the adverse events were experienced. In particular, all of the adverse events that resulted in discontinuation all came from the same site, which is somewhat unusual, and so we're still trying to really understand that and work out how best to manage it. We will allow the use of antiemetics and make those available, but on the other hand, we don't want to encourage and allow people to believe that this is something that they're going to experience, because it is something which I think is susceptible to some auto-suggestion. So it's quite a tricky one to manage, and we're actively thinking our way through that at the moment. Okay, yep.

Janet M. J. Hammond: Okay, yep. Thank you for all the granularity and

Operator: Next one on the queue is Roana Ruiz from SBB Lyrinc. Your line is now open.

Operator: Drink, your line is now open.

Unknown Attendee: Hi, thanks for taking the question. A couple of questions regarding Morning Sky.

Unknown Attendee: Regarding Morning Sky, I was curious; in your protocol amendment plan, would you possibly explore going for an even shorter time period than five days of symptom onset? As I believe I think Pfizer's interim trial had less than three days of symptom onset or less. So we're going to allow patients who have had symptoms for five days or less. I think we will certainly try to ascertain whether their symptom duration was shorter than that, and we could certainly analyze by shorter duration and see whether that has an impact.

Unknown Attendee: There was a small impact, I think, in the Pfizer study, but it actually was surprisingly little, I thought. I mean, I think it was 87 versus 89 percent, so shorter is obviously better, but I don't think it made as much of a difference as I was expecting.

Janet M. J. Hammond: Okay, that makes sense. And I was also curious, in the remarks, how it sounds.

Janet M. J. Hammond: Like you will run the new Morning Sky protocol by the FDA. So does that mean that you're taking steps toward opening some trial sites in the US, or could you just give us an update on where that stands right now? That would be great. I can give you a broad update, which is that we continue to engage with the FDA, and we will be sharing the protocol with them, and we have ongoing positive dialogue, and we do hope that we will be enrolling patients in the U.S. in the study. But I think that's about what I can say.

Janet M. J. Hammond: Okay, fair.

Operator: And if there are no further questions in the queue, I will now turn the call over back to the presenter.

Operator: Over and back to the presenters.

John F. Vavricka: So again, thank you very much for your participation, and I would like to thank everyone, and thank you again. Good night.

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

unknown: BF-WATCH TV 2021 Atea Pharms is a non-profit organization that provides services to the people of the United States. It is a non-profit organization that is committed to providing services to the people of the United States. The program is a partnership between Atea Pharms and the U.S. Department of Health and Human Services. Atea Pharms is a nonprofit organization that provides services to the people of the United States.

Operator: Good afternoon, ladies and gentlemen.

Operator: Welcome to Atea Pharmaceuticals.

Jonae R. Barnes: Atea Pharmaceuticals Thank you, Operator. Good afternoon, everyone, and welcome to Atea Pharmaceuticals' third quarter 2021 Financial Results Conference call. This afternoon, we issued a press release that outlines the topics 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 investor section of our website at www.ir.ateafarma.com. With me today from Atea are our Chief Executive Officer and Founder, Dr. John Pierre Samodossi, Chief Development Officer, Dr. Janet Hammond, Chief Financial Officer and Executive Vice President of Legal, Andrea Corcoran, and our Chief Commercial Officer, John Vavricka. They will all be

Jonae R. Barnes: As outlined on slide 2, I would like to remind you that today's discussion will contain forward-looking statements that involve risk and uncertainties. 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.

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

John F. Vavricka: In addition to the financial results, we have a number of updates for 8527 to review, including an amendment to the Phase 3 Morning Sky trial protocol and a plan to accelerate its enrollment, quantitative infectious virus assay data from the Moonson trial, confirming potent and rapid antiviral activity for ATE527, and new in vitro data for ATE527, demonstrating potent antiviral activity against the major variants of concern or interest, including Delta I will begin on slide 3.

[music].

John F. Vavricka: Atea 527, our already administered product candidate for COVID-19, is a direct acting anti-viral agent derived from our purine nucleotide product platform. Atea 527 is designed to protect against disease progression and the development of long-term COVID complications. Given the evolving dynamics of COVID-19, which is becoming endemic, medical intervention and all therapeutics, in particular, will be essential in stemming the tide of this pandemic and future surges. 85 to 7 targets viral RNA polymerase, a highly conserved enzyme critical to viral replication and transcription. Uniquely, AT527 has a mechanism with dual targets.

John F. Vavricka: It is a chain terminator without introducing new mutations in the virus, and it also inhibits NIRAN, thus providing the potential to create a high barrier to resistance and antiviral activity across variants, as we will share with you in a few minutes. Atea 527 has been shown to be generally safe and well-tolerated. Of particular note, Atea 527 is not mutagenic, with no reproductive toxicity, and it's non-teratogenic. We expect minimal drug-drug interaction since 8527 is a weak inhibitor of cytochrome P450 3A, and no dose adjustment is expected for co-administration of drugs that are CYP3A substrates, which account for the metabolism of more than 50% of clinically relevant drugs.

John F. Vavricka: So this should make our drug candidate prescriber-friendly on slide four. COVID variants of concern continue to create new challenges for treatment and prevention. These variants can also make the execution and evaluation of clinical trial results more challenging because of the impact and differences in viral kinetics as well as clinical symptoms. However, ongoing SARS-CoV-2 genomic surveillance worldwide has improved our ability to rapidly identify such variants. As you can see on this chart, almost 6,000 variants have been sequenced, an outstanding number.

Good afternoon, ladies and gentlemen, welcome to the <unk> Pharmaceuticals third quarter 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 Jenny.

Ours senior Vice President of Investor Relations and corporate Communications at Teva Pharmaceuticals. Please proceed.

John F. Vavricka: The evolution of the virus will make COVID-19 endemic with the ability to continue circulating for years to come. SARS-CoV-2 variants of interest have been associated with increased transmissibility, Neutralization Resistance, and Disease Severity.

Thank you operator, good afternoon, everyone and welcome to pay of Pharmaceuticals third quarter 2021 financial results Conference call. This afternoon, we issued a press release, which outlines the topics. 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 website.

John F. Vavricka: The continuing spread of Delta has led to a new subtype called AY.4.2 or Delta Plus, which carries additional mutations. Although the original Delta variants remain the most dominant on a global basis, this new mutant now accounts for 14% of infections in the UK, up from less than 4% just early September, and is more likely contributing to the recent surge of the fifth wave of COVID in Western and Eastern Europe and other global areas.

At IR Dot Italia farmer Dot Com with me today from the Taylor, our Chief Executive Officer, and founder Dr. Johns Here, Simon does see Chief Development Officer, Dr. Janet Hammond, Chief Financial Officer, and Executive Vice President of legal Andrea Corcoran, and our Chief Commercial Officer, John got Great, though they will all be avail.

But for the Q&A portion of today's call before we begin the call as outlined on slide two I would like to remind you that today's discussion will contain forward looking statements that involve risks and uncertainties. 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.

John F. Vavricka: Preliminary evidence suggests that Delta Plus spread between 12% and 15% more frequently among household members compared with other Delta viruses and will likely become an important strain, including in the U.S. Moving to slide six. As you know, we have previously shown that AT511, the free base of AT527, is a potent inhibitor of SARS-CoV-2 in vitro. The average EC90 in primary human airway epithelial cells against the original virus isolated in early 2020 was around 0.5 micromole, with a five-fold assay, approximately assay to assay variability, as you can see in this slide.

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.

Thank you John and good afternoon, everyone and thank you for joining us today.

<unk> to the financial results. So we have a number of updates for <unk> 85 to seven to review it.

Clothing, and the amendment to the phase III <unk> trial protocol and the plan to accelerate enrollment.

Quantitative.

Infectious virus assay data from the months on trial.

Confirming potent and rapid antiviral activity of 485 to seven new in vitro data.

John F. Vavricka: We recently evaluated our drug candidates against the major variants of concern or interest, including Alpha, Gamma, Epsilon, and more recently Delta, consistent with its dual mechanism of action. AT511. Maintain its potency against all the variants tested, including Dow's. We believe that this data confirms the key mechanistic advantage of this direct candidate, which targets the highly conserved viral RNA polymerase. In fact, we have analyzed over 3 million SARS-CoV-2 sequences deposited in the database today and found that less than 0.01% have mutations near the active site of the SARS-CoV-2 virus. With that, I will now turn the call over to Janet for a more detailed review of our clinical progress.

<unk> 85 to seven demonstrating potent antiviral activity against the major variance of concern.

Including Delta.

I will begin on slide three.

85 to seven O. All the administered product candidate for COVID-19 is a direct acting antiviral agent derived from all peering nuclear tied towards the platform.

Five to seven is designed to protect against disease progression and the development of long carbon complications.

Given the evolving dynamics of COVID-19, which is becoming endemic medical intervention in all therapeutics in particular.

We'll be essentially stemming the tide of this pandemic and future soldiers.

85 to seven targets viral RNA polymerase.

Highly conserved enzyme critical to viral application in transcription.

Uniquely.

85 to seven there's a mechanism with dual targets. It is a change.

Without to ensure the introducing new mutations in the virus and it also inhibits in Iran. Thus, providing the potential to create a high barrier to resistance and antiviral activity.

Janet M. J. Hammond: Beginning with slide A. As you can see on this slide, our robust clinical program includes six studies of 85 to 7, which are running in parallel. We are leveraging lessons learned from each of these studies to better serve our patients and updating our program in real time. There are two key updates on this slide, which include advancing the 85 to 7, 1100 milligram BID dose in the hospitalized study. And we expect results from the next cohort in the first half of next year.

We will share with you in a few minutes.

And also in all studies.

Five to seven was shown to be generally safe and well tolerated.

Particularly of note 85 to seven is not mythogenic with no reproductive toxicity and its known that onto Janet.

We expect minimal drug drug interaction since 85 to seven days, a week and EBITA.

I forgot before fifty-three AA and no dose adjustment is expected for co administration of drug that does <unk> substrate, which account for the metabolism of more than 50% of clinically relevant drugs. So this should make our drug candidates prescriber.

Janet M. J. Hammond: In addition, we are amending the Phase 3 MorningSky trial protocol with a new primary endpoint, a refined patient population, and an increased dosage. And we have a plan to accelerate enrollment completion. I will review the MorningSky updates towards the end of my presentation.

Ah prescribed with friendly.

On slide four.

Carbon variance of concern.

To create new challenges for treatment and prevention.

This variance can also make the execution and evaluation of clinical trial results more challenging because of the impact in differences in viral kinetics as well as clinical symptoms.

Janet M. J. Hammond: As COVID-19 has continued to evolve, so have the ways to quantify the virus. After considerable effort, an optimized infectious virus assay is now available to quantify viable infectious virus in addition to the RT-PCR assay, which measures all forms of viral RNA obtained from the sample, regardless of whether it is from intact replicating virus or from non-viable virus or simply viral fragmentation. This difference is important because it should be a more accurate assessment of the impact of a direct acting antiviral on the ongoing infection.

Ongoing source cough to genomics civilians worthwhile.

Has improved our ability to rapidly identify such variance.

You can see on this chart.

Almost 6000 variants have been sequenced with an outstanding number the evolution of the virus will make COVID-19 endemic with the ability to continuous circulating for years to come.

Sars Cov, two variance of interest I've been associated with increased Transmissibility.

<unk> resistance and disease severity.

The continued spread of downtown.

Led to a new year subtype.

A y thoughtful to our delta plus which carries additional mutation.

Janet M. J. Hammond: I will next review the new viral load results for AT527 from the Rundström trial that we have obtained by using this infectious virus app. Assigned Client on Site-10, Our methodology is quantitative and utilizes the highly sensitive SARS-CoV-2 live virus algorithm. Measuring live virus in nasopharyngeal swab samples from patients has been very challenging for this evolving field, but it is an important advance. Previously, qualitative data from a related type of assay were reported during the development of monocervia.

Although the original Delta variance remained the most dominant on the global basis. This new medicine now accounts for 14% of interactions in the UK.

Up from less than 4% just early September and it's more likely contributing to the research the recent surge of the.

Fifth wave of Covid in Western and Eastern Europe, and all the global areas.

Preliminary evidence suggests the delta plus spread between 12 and 15% more frequently.

Household members compared with all the downtown browsers, and will likely become unimportant strain, including in the U S.

Janet M. J. Hammond: In order to assess more specifically the antiviral effect of our drug candidate by using live virus, our CRO, in collaboration with our partner Roche, has developed an optimized, highly sensitive, and quantitative infectious virus, Pfizer-Ace. As illustrated in this slide, a modified cell line with enhanced susceptibility to SARS-CoV-2 was inoculated with severely diluted native RNG samples, so that we can determine the patient's route. After six days of incubation, positively infected cells were detected by SARS-CoV-2 specific immunostaining.

Moving to slide six.

As you know we have previously shown that <unk> 511, the free base of 85 to seven years.

As a potent inhibitor of Sars cov two in vitro.

Average <unk> 90.

Primary human airway epithelial cells against the original bias isolated in early 2020 was around <unk> five micro mall.

As a fivefold as say approximately.

St USA variability as you can see in the slides.

We recently evaluated our drug candidates against the major variance of concern or interest, including Alpha Gamma Epsilon and more recently delta.

Janet M. J. Hammond: This newly optimized assay has three key advantages. Firstly, it quantifies the infectious virus, thus eliminating the possibility of non-infectious virus or viral fragments by RT-qPCR as previously reported. Earlier assays developed with monopilia reported an infectious virus assay which was qualitative, only positive or negative. No actual Viral Titus Comes, Secondly, this is very accurate. And thirdly, it is highly sensitive.

Consistent with its dual mechanism of faction.

511 maintained its potency against all the variance tested including downtown.

We believe that these data confirm the key mechanistic advantage for this drug candidate, which targets. The a highly conserved viral RNA polymerase. In fact, we have analyzed over 3 million Sars cov two sequences the positive in the database today.

Found that less than 0.0% to 1%.

Isn't mutation near the active side of this.

<unk> 220 mice.

Janet M. J. Hammond: The level of quantification of the assay is equivalent to approximately 10 infectious virus particles per milliliter. Please note that the analysis includes approximately 71% of all patients in Moonsong cohorts A and B who had positive baseline cultures, and 511. Today we are reporting infectious virus data from the Moonsong study. You'll see that in Cohort B, in the overall population, including both high and low risk patients, with the majority being seropositive, 8527 at 1100mg BID-treated patients demonstrated a rapid and potent reduction in the viral load of half-log versus placebo at base 3.

With that I will now turn the call over to Janet for a more detailed review of our clinical programs.

Thank you Sam Kemp.

Beginning with slide eight.

As you can see on this slide.

Buster clinical program includes six.

Okay.

Which are running in parallel.

We are leveraging lessons learned from each other.

Olson.

There's no program in real time.

Two key updates on this trial.

Can you just financing the 85 to seven 1100 milligram B I D. There are some hospitals.

And we expect results from the next cohort in the first half.

In addition, we are amending the phase III Morningstar trial protocol within your primary endpoint.

Refined patient population.

Christa.

And we have a plan to accelerate enrollment completion.

I will review the morning update towards the end of my presentation.

Turning to slide nine.

Janet M. J. Hammond: We are able to see a treatment effect in the subgroup of patients who are at high risk with underlying health conditions, and these results reinforce the exploratory analyses in the same population with RT-PCR in Moonsong and the Phase II study in hospitalized patients. In Cohort B, the acidly treated patient administered 1100 mg BID had a robust viral load reduction of 0.9 of a log at day 3. These data also show a suggested dose response between cohort A and cohort B. Moving to slide 13.

As COVID-19 has continued to fall so just a way to quantify the ball.

After considerable effort and optimized in pictures.

Now available to quantify Zabul infectious virus in addition to the RT Pcr.

Which measures all forms of our R&D massawa.

In the sample.

Regardless of whether it is from intact reputation daragh Quinn from <unk>.

Bob.

Austin, Keith Pfeil Frac.

This is important because it should be a core asset.

The impact of a direct acting antiviral on the ongoing infection.

Janet M. J. Hammond: As I have just outlined, these additional data from the Phase II Moonsong trial support the rapid and potent antiviral effect of AC527 as measured by a quantitative, highly sensitive infectious virus assay that detects live viruses capable of replication. Leveraging the lessons from Moonsong and, as outlined in slide 14, as well as other recent results, we are submitting amendments to the Global Phase III MorningSky trial. MorningSky is a randomized, double-blind, multi-center, placebo-controlled, phase 3 trial evaluating the antiviral activity, safety, and pharmacokinetics of AT527 in approximately 1,600 patients randomized one-to-one to receive AT527 or 1100 mg twice a day or placebo.

Our next are you then you volunteered results analyst conference call.

We have obtained by using this infectious virus backbone.

Obama signed on slide Tom Amato.

Methodology is quite powerful and utilize the highly sensitive Sars COVID-19 two lives.

Awesome.

Measuring wildfires in the nasal pharyngeal swab samples from patients has been very challenging for this evolving field.

But it is an important advance.

Please proceed quantitative data from a related party. It was reported during the development of ammonia turbo.

In order to request.

Cool antiviral effect of our drug candidate by using dive bars.

Yeah.

In collaboration with our partner Roche has developed and optimized highly sensitive and quantitative infectious virus Pasha.

As illustrated in the cloud.

Your line is open.

Two class <unk> wasn't.

Jeremy tenures with mobile Hangzhou samples, so that we can determine the cause for a while.

Janet M. J. Hammond: Together with Roche, we plan to leverage the existing operational global infrastructure from the Morning Sky clinical trial site and Expanded Footprint with approximately 300 sites in New Geography. We expect to report data from this trial in the second half of 2022. Amendments to our Morning Sky study include the following: changing the trial's primary endpoint to COVID-19 related hospitalization or all-cause mortality. The previous primary endpoint of time-to-alleviation or improvement of COVID-19 symptoms will become a secondary endpoint, while refining the patient population to include only unvaccinated high-risk individuals.

Thank you Paul Al Disinfecting wet clutch <unk> cave two specific immunity.

This newly optimized also has three key at Boston.

Please quantify infectious Val.

Eliminating the possibility of northern Texas bar, so while fragments biotic <unk> previous airports.

I guess first developed with monitor their reported infectious virus assay with just quantitatively any positive or negative.

Actual barrel okay. Thank you.

This is very accurate and Saatchi is a highly sensitive to the level of question question.

Is equivalent to approximately Ken will touch his boss posh postponement of Lisa.

Please note that the analysis includes the approximately 71% of all patients and Lin song cohorts, Andy who have positive comps.

On slide 11.

Janet M. J. Hammond: And lastly, increasing the dose of 85 to 7 to 1100 milligrams twice daily from 550 milligrams BID. Patients enrolled in MorningSky have the option to be enrolled in Lederspring, a six-month long-term follow-on study conducted in collaboration with Roche to evaluate long COVID in patients who received 85-7 in comparison to placebo in MorningSky. Let's now turn to HE752, our program for the treatment of prophylaxis of dengue fever on slide 16. Earlier this year, we initiated a randomized, double-blind, consequence-controlled, single- and multiple-ascending-dose Phase I study to evaluate the safety, tolerability, and pharmacokinetics of A2752 in healthy subjects.

Today, we are reporting such size those Halloween song study.

You'll see that can cohort b and the.

Overall population, including both high and low risk patients with the majority being positive.

H five to seven at 1100 milligrams B I D trait to patients.

Strange of Rockford, and the introduction of viral load.

<unk> versus placebo.

Turning to slide 12.

We're able to see a second to talk with patients watch houses with underlying health conditions and these results reinforced exploratory analyses in the same population with RT PCR Nanchang and the phase two study in hospitalized patients.

In total.

The absence of treated patients administered 1100 milligram B I D.

Robust following the introduction of <unk>.

Your line for logs at day three.

These data also.

So Jeff dose response between cohorts.

Okay.

Moving to slide 13.

Janet M. J. Hammond: We have completed part one of the study, the single ascending dose cohort, and in part two, the first two cohorts are complete, and the last cohort is ongoing. We expect the conclusion of this study by year end. During the first half of 2022, we expect to initiate our Phase II study of H.E.752 for the treatment of dengue fever in Asia and South America. In this trial, we will enroll adults with a fever greater than 38 degrees within 48 hours of probable dengue infection and a positive result on the MS-1 antigen test and 4RT-PCR assay.

As I have just outlined in addition.

Data from the phase III trials support the rapid and potent antiviral effect of 85 to seven.

As measured by quantitative Harley center prevent Jetstar, zaslow, which the tech logos capable of replication.

Leveraging the lessons from Mervin song.

Okay inside 14, as well as other recent results, yes, switching amendments to the global Phase III Morningstar trial.

Good morning, Scott is a randomized double blind multicenter placebo controlled phase II trial evaluating the antiviral activity safety and pharmacokinetics 85 to seven and approximately 1600 patients randomized one to one to receive 85%.

Janet M. J. Hammond: The primary endpoint will be changed to viral load from baseline. We look forward to keeping you apprised of our progress in this important study next year. With that, I will now turn the call over to Andrea for a review of the finances. Thank you, Janet.

And that 100 milligrams twice a day or placebo.

Together with Roche plans to leverage the existing operational global infrastructure from the morning squad clinical trial site.

And expand its footprint with approximately 300 sites in new geographies.

Andrea J. Corcoran: As Jonae mentioned in her introductory remarks, this afternoon, we issued a press release containing our financial results for the third quarter of 2021. The statement of operations and the balance sheet are on slides 18 and 19. For the third quarter of 2021, the increase in R&D expenses in comparison to the third quarter of 2020.

We expect to report the data from this trial in second half of 2022.

Amendments to our morning Sky Becky to hiring.

Changing the trials primary endpoint to COVID-19 related costs.

Ocean all cause mortality.

Previous primary endpoint of time to alleviation or improvement as COVID-19, Sinton will become a secondary endpoint.

Refining the patient population to include Ernie vaccinated high risk individuals.

Andrea J. Corcoran: The increase in general and administrative expenses was primarily due to the expansion of our organization in 2021 and consists principally of an increase in payroll and personnel-related expenses. I am pleased to report that we ended the third quarter with a strong balance sheet to support our clinical development program. As of September 30,

And lastly, increasing the dose of 85 to seven to 11 countries into grams twice daily from 550 milligrams B I D.

Patients enrolled in morning Sky have the option to be enrolled in later spring.

Six month long term follow on study conducted in collaboration with Roche to value with lung cancer in patients who received 85 to seven in comparison to placebo <unk> morning, Scott.

Let's now turn to <unk> 75 to a program for the treatment and prophylaxis of dengue fever on slide 16.

Andrea J. Corcoran: In 2020-2021, cash and cash equivalents were $800,000.

Earlier this year, we initiated a randomized double blind placebo controlled single and multiple ascending dose phase one study for.

Andrea J. Corcoran: $839.7 million. This includes the $50 million development milestone the company received in July under our license agreement with Roche. I'll now turn the call back over to Jean-Pierre for closing remarks.

<unk> the safety Tolerability and pharmacokinetics of 80 752 in healthy subjects.

Now completed part one of the study the single ascending dose cocoa and didn't talk too.

Two cohorts are complete and the last critical which is ongoing.

We expect conclusion of the study by year end.

John F. Vavricka: Thank you, Andrea. As Janet outlined, the protocol changes we are making to the Phase 3 MorningSky study maximize our ability to demonstrate a positive clinical outcome. The updated inclusion criteria, dosing regimen, and primary endpoint should allow execution of a more focused and de-risked trial. Importantly, the encouraging infectious virus data we have disclosed today give us further confidence in Atea 527's rapid and potent antiviral activity against COVID-19, which is critical to stopping disease progression and transmission.

During the first half of 2022.

We expect to initiate a phase two study of 80 752 for the treatment of <unk> in Asia and South America.

In this trial, we will enroll at all with a fever cases, and 38 degrees within 48 hours of probable dengue infection and positive results from the <unk>, one antigen test on philosophy PCR assay.

The primary endpoint will be change in wireless from baseline.

We look forward to keeping you apprised of our progress in this important study next year.

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

Thank you Janet.

Your name mentioned in her introductory remarks. This afternoon, we issued a press release containing our financial results for the third quarter of 2021 statement of.

John F. Vavricka: We continue to be very excited by the opportunity Atea has to change the course of COVID-19. Thank you, in favor of Hepatitis C and all of our in-patients. This is an exciting time to be bringing forth what we believe to be groundbreaking technologies, and we look forward to updating you on our progress. As always, we thank you for your continued support as we build Atea into a global leader in the discovery, development, and commercialization of oral therapies that address the unmet medical needs of patients with life-threatening bowel disease. With that, Operator, we will now open the call to your questions.

Operations, and the balance sheet or on slides 18, and 19 for.

For the third quarter 2021, and the increase in R&D expenses in comparison to the third quarter of 2020 was principally driven by an increase in external clinical development and manufacturing expenses incurred primarily in conjunction with the advancement of <unk> 37 for the treatment of COVID-19 and to a lesser extent.

It keeps them in part two which is being developed for dengue fever. These expenses include our share of close to five years and increases in internal 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 in 2021 and consists principally and an increase in payroll and personnel related expenses.

Operator: Alright, so 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. Again, that is star 1 on your telephone. Please stand by while we compile the Q&A roster.

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

As of September 32021, cash and cash equivalents were 839 7 million.

Eric William Joseph: The first question comes from the line of Eric Joseph from J.P. Morgan. The line is now open. Hi, good afternoon.

This includes the $50 million development milestone the company received in July under our license agreement with Roche.

Hannah: Hi, good afternoon; this is Hannah on behalf of Eric. Thanks for taking the questions; just a few from us. So first, just want to get your thoughts on the feasibility of conducting the phase three trial where we have the Pfizer pill, PaxLivid, and MonocularVir accessible. How confident are you in the stated timelines that you've given? And then also with the recently reported remdesivir outpatient trial Pine Tree, which showed a meaningful effect in hospitalization or death, despite a minimal, or really no effect on viral load, I just wanted to get your take on this data set.

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

Thank you Andre as Janet outlined the political changes, we are making through the phase III mornings guys study maximize our ability to demonstrate positive clinical outcome.

The updated inclusion criteria dosing regimen and primary endpoint should.

Execution of a more focused and de risked trial.

Importantly, the encouraging infections raws data, we have disclosed today give us further confidence in 85 to seven and rapid and potent antiviral activity against COVID-19, which is critical to stopping disease progression in transmission.

Continue to be very excited by the opportunity to change the quarter COVID-19, dengue fever, if with AUC and although viral infections. This is an exciting time to be.

Hannah: And then from a theoretical perspective, what other than viral load reduction do you think might translate to an effect on clinical outcomes? Thank you. So with regard to the feasibility of conducting the study, we believe that it's still feasible, and in some ways, I think it's unfortunate that it is, but I think vaccine rollout across the world, while impressive in many places, is lagging in many others, and I think that, unfortunately, this provides an opportunity for many high-risk patients still to be susceptible to the disease. We have an extensive footprint already and plan to have a still further extensive footprint as we move forward.

Bringing for us what we believe to be groundbreaking technologies and we look forward to updating you on our progress.

As always we thank you for your continued support as we build that into a global leader in the discovery development and commercialization of all therapies that address the unmet medical needs of patients with life threatening viral diseases.

With that operator, we will now open the call up to your questions.

Alright, so 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.

Again that is star one on your telephone please standby will be composite G&A roster.

First question comes from the line of Eric Joseph from Jpmorgan. Your line is now open.

Hi, Good afternoon. This is Hannah on for Eric Thanks for taking the questions just a few from us.

John F. Vavricka: As I mentioned, we'll have more than 300 sites or thereabouts in the trial and so we believe that study ought to be able to be enrolled and completed in the timeframe that we suggested. And then with regard to remdesivir, I wasn't completely sure that I understood your question. I think that what remdesivir showed very elegantly and in a large study was really that there was no correlation between viral load and clinical effect and I think that probably that is true in general for the direct acting antivirals, particularly when measured by RT-PCR and I think really some of what we have attempted to show today is really that in addition to RT-PCR, which seems to be a rather blunt tool and I think is recognized as such, the live virus assay that we have reported on seems to be somewhat more able to discriminate between viral fragments and non-viable virus and actual live virus and I think we're actually showing quite nicely even a suggestion of a dose response in what we're seeing there.

First just wanted to get your thoughts on the feasibility of conducting the phase III trial, where we have the Pfizer pill counts with it and monitor their acceptable how confident are you in the state of the timelines that you've given.

And then also with the recently.

Reported when does appear outpatient trial pine tree, which showed a meaningful effect in hospitalization or death.

Fight, a minimal or really no effect on viral load just wanted to get your take on this dataset and then from a theoretical perspective.

What other than viral load reduction do you think might translate to an effect on clinical outcomes. Thank you.

Janet.

I'll ask both questions. Please.

Thank you yeah sure with.

With regard to proceed we believe she is conducting the study.

I'm still feasible and in some ways that I think it's unfortunate.

Correct.

I think saskatoon rollout across the work.

While impressive in many places is lagging and many others and I think that Unfortunately this provides an opportunity for really.

Many high risk patients.

Understood disease, we have an extensive.

Print.

And and tend to have a still further.

The footprint as we move forward as I mentioned, we'll have more than 300 plus or.

Or thereabouts.

And so we believe that.

<unk> to be able to be.

Enrolled and completed in the timeframe that you suggested.

And then with regard to them does that wasn't continues to show that I understood. Your question I think that Walkman desert.

John F. Vavricka: Certainly, clinical endpoints are really what it's all about ultimately, and that's what we all care about, whether the patient gets better, and if we can prevent hospitalization and find some surrogate endpoint which is able to help support that, and, ultimately, it could be a useful surrogate end point, that would be great, but I think the Remdesivir data actually are supportive of the field in general and what others are Okay, great. That's helpful. Thanks, Julia. Next one on the queue is Jonathan Miller from Evercore ISI. Your line is now open. Thanks so much for taking the questions, guys.

Sure very elegantly and in a large study where Randy that there was no correlation between viral loads and clinical effect and I think thats perfectly that is true.

General for the direct acting antivirals, particularly when measured by oxy.

Oxy, PCR and I think I'm really kind of work.

We have attempted shirt. Okay is Randy that in addition to RT, PCR, which seems to be a rather blunt tool and I think as recognized as such.

Live virus assay and that we have reported on seems to be somewhat more able to discriminate between.

Charles fragments and nonviable darice, an actual live virus and I think we're actually sharing quite nicely and even the suggestion of a dose response in Walker seeing that suddenly clinical endpoints are really what it's all about ultimately unethical karabakhis sensitive patients gets better and if we can prevent hospitalization and find some sorry.

Jonathan Miller: I have a couple of, maybe more detailed ones, on some of the data you released today.

unknown: Unknown Attendee, Jonathan Miller, Nikola Gasic, Rosa Chen, Atea Pharms, Atea Pharms,

Argus endpoint, which was able to help them support and.

unknown: [inaudible]

Jonathan Miller: Following on from the last question, it seems like the majority of the patients on the 1.1

Ultimate very useful target endpoint that would be great.

I think the Rem density epic data actually are supportive of the field in general than what others are experiencing a renaissance.

Jonathan Miller: It seems like the majority of the patients on the 1.1 gram arm in Phase II were high-risk. And just trying to back out, obviously it's tough to do with my head on a long scale, but is it fair to say that the viral load impact in low-risk patients is really pretty modest? And then following on that prior question, If you think that there's not a good read-through from viral load to clinical efficacy, do you expect that direct-acting antivirals, maybe broadly, will have a meaningful clinical impact in low-risk patients? And I'll, I guess I'll pause there until at least that's it. Janet?

Okay, Great. That's helpful. Thanks for taking the questions.

Thanks, Simona Q is Jonathan Miller from Evercore ISI. Your line is now open.

Thanks, so much for taking the questions guys.

I have a couple of maybe more detailed ones on some of the data we released today.

You mentioned that your phase II cohort is majority of tier a positive I think you said, 71% of your positive baseline how different are the result, there between sera positive and negative patients at baseline for one.

And then secondly.

Sort of following on the last question. It seems like the majority of the patients on the one one gram arm in the phase two were high risk.

And just trying to back out if you can talk to you in my head on large scale, but it's fair to say that the viral load impact in low risk patients is really pretty modest and then following on that prior question.

Janet M. J. Hammond: Yes, seropositivity was actually very high and perhaps not surprisingly increased, I think, as the study went on, although we're still awaiting some of the final serology data from Cohort A. But certainly, in Cohort B, 87% of the treated patients were seropositive, and I think 80% in the placebo group, so really high numbers. And I think that does blunt what you're able to see. Perhaps it blunts it less, I think, in the high-risk patients than in the other ones, but I think essentially what we're seeing, and I think it perhaps answers some of your second question, too, around the bowel-load impact in the low-risk patients. I think clearly, if you're low risk, you're able to clear the virus, perhaps more effectively yourself without the need for a direct acting antiviral.

If you think that there is not a good read through from viral loads of clinical efficacy do you expect that direct acting antivirals, maybe broadly will have a meaningful clinical impact in low risk patients.

And I guess I'll pause there to allow middle East Africa.

Janet.

Sure. Thanks, John.

In regards to your question around the share of positivity yesterday Mercury productivity was actually I'm very high on and.

Perhaps not surprisingly increased I think.

<unk> totaled Arista are raising some of the final I'm sure all of you guys.

But secondly, and critical B.

87% of treated patients with <unk> positive and I think.

The placebo group really high number.

And I think that the plant what youre able to see.

Has it gone six months I think in the high risk patients than in the other ones, but I think essentially to work with being perhaps answer some of your second question two around the <unk> impact and the low risk patient I think Kelly if you wonder risks are able to kill the virus, perhaps more aggressively yourself without.

The need for a direct acting antiviral.

Janet M. J. Hammond: But I think if you're able to prevent hospitalizations, and as others have demonstrated preventing hospitalizations and death in high-risk patients, you have to believe that you're having a similar effect, although it's harder to measure in patients who are at lower or more modest risk for those types of outcomes. But nevertheless, I'm certain that you're probably shortening the duration of symptoms. And this is something that we have been hoping to demonstrate in our phase three trial.

But I think if youre able to prevent hospitalizations and drew I think as others have demonstrated preventing hospitalizations and death in harvest cushion believes.

Believes after having a similar effect, although it's harder to measure in patients who are at.

<unk> or modest Chris for those types of outcomes, but nevertheless.

Second that you'll you'll probably shortening the duration of symptoms and this is something that had been hurting too demonstrated in our phase II trial, but it seems that this harder endpoints are suddenly.

Janet M. J. Hammond: But it seems that these harder endpoints are certainly easier to document. And I think that that points us to why we're going in the direction that we are with morning sky. But I think that if you're showing those types of benefits in high-risk patients, we need to refine the tools in which we demonstrate that in order to protect high-risk patients, you're clearly also showing benefits in lower-risk patients, albeit viral load, and particularly RT-PCR, isn't the perfect measure.

Easier to document and I think that that's frankly.

Pilot going in the direction that we all with Morningstar right, but I think critical showing the types of benefits of high risk patients.

We need to refine the tools in which we demonstrate that in order to protect high risk patients or penny also showing benefits and nervous patients, albeit.

Thyroid and particularly by RT PCR is in fee.

Perfect measure, but I think I think you can see that there are reductions in viral load across the board I think just the higher risk patients perhaps.

Janet M. J. Hammond: But I think you can see that there are reductions in viral load across the board. I think just the higher risk patients, perhaps less surprisingly, also tend to start off with higher loads. And clearly, you need to have a bigger delta to be able to demonstrate something. So I think it all tells the same story quite cohesively. I hope that answers the question.

Surprisingly also do tend to start off with high loads and Kelly you need to have a.

Hey, good delta to be able to demonstrate something so I think I think it all.

Tells us tells the same story.

I hope that answered the question.

Janet M. J. Hammond: Yes, somewhat. And then I guess one final one: how are you defining high risk in the new criteria?

Yes, somewhat and then I guess one final one how are you defining high risk in the new criteria.

Janet M. J. Hammond: So I think it's, I think the definition is pretty standard in terms of patients being elderly, obese, diabetic, immunosuppressed, and I think also potentially asthmatic patients with underlying renal disease, underlying tumors, and so forth. And hypertension, and hypertension here, cardiovascular disease.

So I think it's I think the definition is pretty standard in terms of.

Patients being elderly.

It'd be diabetic.

Immuno suppressed.

And.

And I think.

Asthmatic patients with underlying renal disease.

<unk> tumors and social.

Jonathan Miller: Thanks very much, guys. All right.

Hypotension.

And have to pension, yes cardiovascular disease.

Operator: So for the next question, we do have...

Alright, thanks, very much good luck.

Operator: Next question, we do have Tim Lugo from William Blair. The line is now open.

Uh-huh Sir the next question, we do have Tim Lugo from William Blair. Your line is now open.

Timothy Francis Lugo: Thanks for the question and the additional data. I'd like maybe a broader question on, you know, given the recent protease inhibitor data, I'd just love to hear your updated thoughts around targeting the RNA polymerase directly versus the protease. You know, we, I guess, previously were thinking the correlations between HCV and HIV and other more chronic diseases would suggest RNA polymerase was the correct target for, you know, minimizing resistance, but is that still the case, and can we kind of, can we really extrapolate those diseases to SARS-CoV-2 and COVID-19?

Thanks for the question.

Additional data.

I'd like maybe a broader.

Question on given.

Given the recent impressive protease inhibitor data I'd, just love to hear your updated thoughts around targeting will be on a preliminary directly versus the Purdue.

We.

As previously were thinking the correlations between HCV and HIV and other more chronic diseases.

We are in Oklahoma <unk> was the.

<unk> targets for minimizing resistance.

Is that still the case.

And can we.

We really extrapolate those diseases.

Two and COVID-19.

John F. Vavricka: Well, look, first of all, we welcome really all progress in developing treatments as part of a multi-pronged approach to combat the COVID-19 pandemic. And as there are several vaccines, we believe that multiple treatment options will be needed. So in that regard, I don't think that one target is going to be better than the other one.

Well look first we won't come really all progress in developing treatments as part of a multi pronged approach.

Two.

To combat Covid, 19, pandemic and and as there is several vaccines.

We believe that multiple treatment options would be needed.

So.

Regarding.

I don't think that.

One targets.

Going to be better than than the other one.

John F. Vavricka: You have seen the data, as I just mentioned about remdesivir in the outpatient setting, and fortunately, the drug can be given only IV, and obviously, we know the limitations. But I think we have not seen from Pfizer all the detailed analysis of the data, talking about viral load, and talking about the potential for the emergence of resistance. And what I believe, what we believe, is that it's going to be a very different situation in the real world than in clinical trials with protease inhibitors potentially used in immunocompromised patients, used in, so on, with maybe issues with taking all the doses at the right time.

You have seen the data just mentioned about.

The <unk> patient Unfortunately, the drug can be given the only IV and obviously, we know that there are limitations.

I think we have not seen.

From from.

From Faiza, all the detail analysis of the data.

Talking about viral load talking about.

Potential of emergence of resistance.

And what.

What I believe what we believe.

Is that.

It's going to be a very different.

I would say.

Situation.

Real World.

And then in clinical trials for.

For the Ace inhibitors.

Potentially using immuno compromised patients.

Used.

In.

So.

With maybe.

Maybe.

John F. Vavricka: And so we have to see, let's not forget that any drug, any anti-viral drug with one point mutation will very likely lead to resistance. When Tamiflu was launched in 2008-2009, there was absolutely no resistance at all. Just one year later, the majority of the flu strains were resistant to Tamiflu. So, I don't want you to picture a future negative picture of protease inhibitors. But I think we have to be; we can celebrate today; we should celebrate, but at the same time, we need to see the reality for the future.

Issues.

Hum.

Taking all these.

The doses.

Timing and so.

We have to see lets not forget that Amy drug any antiviral drug.

Is one point mutation.

Very likely lead to resistance.

When Tommy flu was launched in 2008 2009, there was absolute team, though is this at all just one year later.

It was the majority of the.

<unk>.

Strange way resistance to resistant Tommy flu, so I don't want to picture.

A future negative.

Hmm.

Picture on protease inhibitors, because I think we have to be.

Can celebrate today, we should celebrate.

But in the same time, we need to.

See the reality for the future as Janet indicated.

John F. Vavricka: As Janet indicated, we are going to have an endemic situation, there will be new strains, and I believe that I would not be surprised that we are going to talk about combination therapies, as you know Tim, potentially the combination of two different classes, PI and NIC have been shown in the past to be a very interesting combination. So I think what we have learned over the last 12 to 18 months is that what we know today may be different in 6 months and, certainly, in 12 months to come. So I would be cautious.

We are going to have an endemic situation there is going to be new strains and.

And I believe that.

I would not be surprised that we're going to talk about combination therapies as you know Tim.

With a potentially.

The combination of two different classes.

And Pi and Nick have been shown in the past to be.

A very interesting combination so I think what we have.

Over the last.

12 to 18 months is what we know today it may be different than six months since surely in 12 months to come so I would be I would be cautious there.

John F. Vavricka: Okay, that's understood, and I agree. I think we're all looking towards the first combination that is going to be incredibly interesting. But I guess generally, when we look across the oral trials and even remdesivir as well, the patient numbers that have been enrolled in the other trials have just been so much higher. I know Moonsong took a while to get underway. Can you just maybe comment on how, you know, MorningSky will be different in terms of patient enrollment and really pushing patient enrollment?

Okay.

Understood.

I agree I think we're all looking towards the first combination.

It's going to be incredibly interesting.

Generally when we look across the oral trials and even run disappear as well.

The patient numbers have been enrolled in the other trials have just been so much higher I know Lin song.

Hook, a while to get underway maybe comments on how you know morningstar will be different in terms of patient enrollment really question patient enrollment because it did take a long time to get those patients.

John F. Vavricka: Because it did take a long time to get those patients. Yeah, you're absolutely right, Tim. We are very aware of that. Janet, could you share basically what we are putting in place, and now we foresee accelerating MorningSky enrollment after we have basically filed and finalized the amendments with the regulatory authorities?

You're absolutely right.

Yes.

Aware of it Janet.

Would you share basically what.

We are putting in place and though we foresee two accelerating the.

In the morning Sky.

Enrollment after we will have.

Basically file and finalize the amendments with the regulatory authorities.

Janet M. J. Hammond: So I think we have increased the sample size somewhat, but we certainly have, I think, really doubled down on the geographical footprint, particularly looking at areas where we're likely to be able to enroll patients who are unvaccinated. And I think with that footprint and also the potential for conducting an interim analysis and so forth, similar to what others have been able to do, we believe that we should be able to meet the timelines that we are committing to and are confident that this is something which is still possible. We realize that the window is going to close as more people become vaccinated and also as treatments become more accessible, but we're certainly committed to doing this and really believe that we can.

Sure I think we have we have increased the sample size somewhat but we we.

And do you have I think really.

<unk> doubled down on the geographical footprint and particularly looking at areas, where we're likely to be able to enroll patients who are vaccinated.

And I think I think with that footprint and also I think BC.

Potential for conducting an interim analysis and cheerful submit it to what others have been able to do we believe that we should be able to meet the timelines that we are committing to.

And and.

Confidence that this is this is something which is still possible. We read is that the window is going to close as mortgage will become back to nature. Then also therapies become more accessible.

We were certainly committed to doing this.

I really believe that we can.

Janet M. J. Hammond: Okay, that's understood. And maybe another question: how many patients had been enrolled in MorningSky by, you know, when you filed the protocol amendment? And, you know, if I recall correctly, I think the higher dose had a bit of a nausea signal. Are you going to be allowing anti-emetics in Morning Sky? And I'd also like to ask you maybe to give us some more details on this additional cohort from Moonsong that we'll be expecting early next year?

Sure Scott.

Understood.

Maybe another 100 patients have been enrolled in Morningstar.

When you filed the protocol amendments.

And Barbara.

If I recall I think the higher dose had a bit of a noise.

Let's ignore or are you going to be around allowing anti emetic. Good morning, Scott.

And I guess also can you maybe give us some more details on this additional cohort from known songs that will be expected early next year.

Sure.

Please proceed with regard to the number of patients is not something that we've disclosed.

Janet M. J. Hammond: So firstly, with regard to the number of patients, it's not something that we've disclosed. Secondly, with regard to the use of anti-emetics, we are going to educate physicians on the fact that there have been some GI side effects. We don't believe that it's a particularly significant one at the moment, but it's certainly something that we are actively managing and also setting up studies to assess how best to address it in terms of potential food effects and protecting patients from feeling these symptoms. And it's something that we're actively working on.

Secondly, with regard to the use of antiemetic.

I'm going to educate physicians on the fact that there has been.

Some Gi signal, we don't believe that.

A particularly significant one scenario, but it's definitely something that we are actively managing and also setting up studies to assess how best to address it in terms of.

Potential food effects and protecting patients from sailing distances.

Something that where we.

We're actively working on.

Janet M. J. Hammond: But we don't actually believe yet that we fully understand the significance of it, as there were some peculiarities with the patients where the adverse events were experienced. In particular, all of the adverse events that resulted in discontinuation all came from the same site, which is somewhat unusual, and so we're still trying to really understand that and work out how best to manage it. We will allow the use of anti-emetics and make those available, but on the other hand, we don't want to encourage and allow people to believe that this is something that they're going to experience because it is something which I think is susceptible to some auto-suggestion. So it's quite a tricky one to manage, and we're actively thinking our way through that at the moment. Okay, yep.

But we werent actually believe yes, exactly fully understand the significance of it.

Some peculiarities with fit pay.

Patients with the adverse events were experienced.

In particular all of the adverse events.

Resulted in discontinuation will come from the same site.

Which is somewhat unusual answer Rick or trying to really understand bathroom warehouse conference to manager we were allowed to use against the metrics and make those available but on the other hand, we don't want to encourage and.

Here allow people to believe that this is something that they're going to experience because it is something which I think is susceptible to some auto suggestion says.

That's a tricky one to Matt as you are and where we're actively thinking our way through that and then and then lastly in regards to your question around noon film rental turning to enrolling the cohort and then stomach leased equipment.

Okay.

Janet M. J. Hammond: Okay, yep. Thank you for all the granularity.

Thank you for all the granularity and.

And all the answers.

Thank you Tim Thank you.

Operator: Next one on the queue is Roana Ruiz from SBB Lyrinc.

Next one on the Q is it rollout Rwanda release from SBB Leerink. Your line is now open.

Operator: The line is now open.

Unknown Attendee: Hi, thanks for taking the question. A couple regarding Morning Sky. I was

Alright, Thanks for taking the question a couple regarding morning Sky I was curious in your protocol Amendment plan would you, possibly explore going for an even shorter time period than five days in symptom onset as I believe I think pfizer's in turn had a less than three days of symptom onset or less.

Unknown Attendee: Morning Sky, I was curious, in your protocol amendment plan, would you possibly explore going for an even shorter time period than five days of symptom onset? As I believe I think Pfizer's interim trial had less than three days of symptom onset or less. So we're going to allow patients who have had symptoms for five days or less. I think we will certainly try to ascertain whether their symptom duration was shorter than that, and we could certainly analyze by shorter duration and see whether that has an impact.

John It's Richard.

Breaking to allow patients.

Who have had symptoms for five days on net I think we will certainly be trying to ascertain whether that symptom duration for churches imagine because that can be analyzed.

Shorter duration and see.

With regard has an impact there was a small impact I think in the phase <unk> study, but it actually was.

Unknown Attendee: There was a small impact, I think, in the Pfizer study, but it actually was surprisingly little, I thought. I mean, I think it was 87 versus 89 percent. Shorter is obviously better, but I don't think it made as much of a difference as I was expecting.

Rising even before <unk> I think it was 87 versus 89%.

Sure she is obviously better but.

I don't think it makes as much of a difference as I was expressing.

Janet M. J. Hammond: Okay, next time. Transcribed by https://otter.ai

Okay makes sense and I was also curious.

In the remarks, it sounded like you will run the new morning Sky protocol by the FDA. So does that mean that youre, taking steps toward openings and trial sites in the U S. Could you just given us an update on where that stands right now that'd be great.

unknown: I was also curious; in the remarks, it sounded like you will run the new Morning Sky protocol by

unknown: Transcripts provided by Transcription Outsourcing, LLC.

Janet M. J. Hammond: Transcripts provided by Transcripts.com I can give you a broad update, which is that we continue to engage with the FDA, and we will be sharing the protocol with them, and we have ongoing positive dialogue, and we do hope that we will be enrolling patients in the U.S. in the study. But I think that's about what I can say.

Right.

Alright, I can give you a broad update which is that we continue to engage with the FDA and we will be sharing with them the first call.

Hum.

Going positive dialogue and we do hope that we will be converting patients in the U S. In the study because I think that's about what Hudson correct.

Unknown Attendee: Okay, fair. Thanks.

Okay, Sir thanks.

Operator: And if there are no further questions in the queue, I will now turn the call over back to the presenter.

And there are no further question on queue I'll now turn the call over back to the presenters.

Operator: And we're back to the presenters.

So again, thank you very much for.

John F. Vavricka: So again, thank you very much for your participation, and I would like to thank everyone, and thank you again. Good night.

Participation in the ROIC.

Thank you everyone and thank you again good luck.

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

Yes.

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