Q4 2020 Atea Pharmaceuticals Inc Earnings Call

Good afternoon, ladies and gentlemen, welcome to the I T at the pharma Shelby costs full year, 2020 financial results Conference call.

Operator: Good afternoon, ladies and gentlemen. Welcome to the Atea Pharmaceuticals Full Year 2020 Financial Results Conference Call. At this time, all participants are in a listen-only mode.

Time, all participants are in a listen only mode following to form up and Mark We will open the call up for your questions I would now like to turn the call over to <unk> Senior Vice President of Investor Relations and corporate communications at the payoff on a machete golf. Please proceed.

Operator: Following the format remarks, we will open the call up for your questions. I would now like to turn the call over to Jonae Barnes, Senior Vice President of Investor Relations and Corporate Communications at Atea Pharmaceuticals. Please proceed.

Great. Thank you operator, good afternoon and I'll.

Jonae R. Barnes: Thank you, Operator. Good afternoon, everyone, and welcome to Atea Pharmaceuticals' full-year 2020 Financial Results Conference. Earlier today, we issued a press release that outlines the topics we plan to discuss. You can access the press release as well as the slides that we'll be reviewing today by visiting the Investors section of our website at irateafarma.com. With me today from Atea are Founder, Chairman, and Chief Executive Officer, Dr. Jean-Pierre Samadosi, Chief Development Officer, Dr. Janet Hammond, and Chief Financial Officer and Executive Vice President of Legal, Andrea Corcoran.

Welcome to you and Teva Pharmaceuticals, full year, 2020 financial results Conference call.

Earlier today, we issued a press release with the topics we plan to discuss.

You can access the press release as well as price that we're reviewing today via the investors section of our website at IR and tell your farm and Dot Com with me today from a payer or faster chairman and executive officer doctors on per semi Joshi, Chief Development Officer, Dr. Janet.

And Chief Financial Officer, Executive Light Jets and enough legal Andrea worker.

Jonae R. Barnes: Our Chief Commercial Officer, John Vavricka, will also be available for the Q&A portion of today's call. Before we begin the call, 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 Chief commercial officer, John Gregory Chow will be available for the Q&A portion of today's call.

Yeah.

Before we begin the call from.

To remind you that today's discussion will contain forward looking statements that involve risks and uncertainties. These risks and uncertainties are out and 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 turn the call over.

Jean-Pierre Samadosi: Thank you, Jonae, and good afternoon, everyone. Thank you for joining us today on our first Investor Earnings Call since going public in the first quarter of last year. 2020 was a transformational year for Atea, and we are happy to review with you the corporate and clinical progress we have made and to share our roadmap for the year ahead. Since founding the company, our vision has been for the discovery and development of antiviral drugs for the treatment, cure, and possibly prophylaxis of severe viral diseases where there is a significant unmet medical need where we can make a huge difference in patient life.

To John here.

Thank you John and good afternoon, everyone.

Thank you for joining us today on that one.

First investor call since going public and of course walnuts one on steel.

Slide 20, it was a transformational year.

And we are happy to review with you the corporate and clinical progress, we have made and to share on the roadmap.

And from the founding.

On the company our vision has been on the describing and Denver loved ones on antiviral.

Thank you valda drags on the treatment Q and possibly prophylaxis of severe viral diseases, where there is a significant unmet medical need and where we can make a huge difference and patient lives.

Jean-Pierre Samadosi: While there has been a great deal of progress in the treatment of a number of viral diseases over the last 40 years, many RNA viruses continue to have no available treatment and remain the cause of severe global diseases. Today, we have a perfect example with the current COVID-19 pandemic caused by SARS-CoV-2.

And there has been a great deal of progress and the treatment on a number of diseases over the last 40 years and many have any balance sheet continues to have no available treatment and remain that goes on.

Severe global diseases today.

A perfect example used accounts.

Coffee and 19 and damage caused by Sars Cov two.

Jean-Pierre Samadosi: Early last year, our antiviral platform put us at the forefront of this fight. As we are now a year into this pandemic, SARS-CoV-2 is increasingly likely to become an endemic human coronavirus that has the potential to circulate among us for years. Multiple COVID-19 preventive and therapeutic treatments will be essential to manage this virus. Our purine nucleotide prodrugs have pharmacological properties that are uniquely suited to the treatment and prevention of these viral diseases. Our drug candidates are designed to target viral RNA polymerase, a highly conserved enzyme critical to the life cycle replication of this virus.

Early last year, I will and Steve our platform put us on the fun of this fight.

As we on a year into this pandemic Sars cov, two is increasingly likely to become and then and then damage human coronavirus and it has the potential to circle and long guns for us.

Simple hobby, and 19, preventive and Tim and beauty treatments will be essential to manage these bonds.

Ill appealing nucleotide projects from income.

Logical and properties that are uniquely suited for the treatment and prevention from these are all diseases. Our drug candidates are designed to dog and bottler them and they preliminaries are highly conserved enzyme critical to the light side.

I couldnt be case and those devices.

Jean-Pierre Samadosi: Our platform offers many advantages, including potent and selective antiviral activity, convenience of oral administration, and scalable manufacturing, all essential when targeting millions of patients worldwide. Turning now to Slate 4, we made tremendous clinical progress last year. With 85 to 7, we quickly moved to advance the COVID-19 program, filing an IND, initiating a Phase 2 trial in hospitalized patients. In addition, a Phase 2 virology trial in the outpatient setting is also ongoing. Importantly, we anticipate initiating a global Phase 3 program with our strategic partner, Roche, in the second quarter. Janet will provide further details on our clinical programs later in the call.

I will platform.

And as many advantages, including potent and selective into volume activity.

Convenience or administration and.

And scalable manufacturing oldest central and when targeting minions of patients worldwide.

Turning now to slide four we made tremendous clinical progress last year.

And as 85 to seven and we quickly moved to advance a COVID-19 program finding a 90 day initiating a phase II trial and hospitalized patients. In addition, and face to virology trial and the outpatient setting is also growing importantly, we anticipate initiating a global phase III.

Graham with our strategic Paul on the roads in the second quarter and Janet will provide those details on our clinical programs lay the and the cool.

We have also been very active.

Jean-Pierre Samadosi: We have also been very active in publishing and presenting our results. A manuscript Highlighting Preclinical Results of 85-7 in COVID-19 was recently published in Antimicrobial Research and Chemotherapy, and Favorable Phase I Results were presented in March at COI. This month, we were also invited to present supportive data on 85 to 70 COVID-19 at the International Conference on Antiviral Research, or ICAR. In addition, we have diligently worked to elucidate the dual mechanism of action of 8527 and are submitting a manuscript detailing this and the unique interaction with 1890-10 against SARS-CoV-2 RNA polymerase. We expect publication of those data in the near term in a peer-reviewed journal. In the meantime, we and our collaborators thought that this groundbreaking research relating to COVID-19 should be shared with the world's scientific community.

Shang and presenting our results and <unk>.

On the script highlighting preclinical results from phase five to seven from COVID-19 was recently published and antimicrobial agents and chemotherapy and favorable and phase. One results were presented in March at CT and <unk>.

This month, we were also invited to present and supportive data when they see price and Saturday and COVID-19 and at the end.

International Conference on antiviral research or I call in.

In addition, we have diligently worked to elucidate the dual mechanism of faction of 85 to seven and now submitting a manuscript detailing this and the unique interactions with 18 90 10 against Sars cov on when they put in place.

We expect lubrication and those day those in the near term and the peer reviewed journal in the meantime, we and I would call up and ready to start that this ground breaking research relating to COVID-19, and should be share was the word scientific community on bio archive.

Jean-Pierre Samadosi: Turning now to our 8752 program. We recently initiated a Phase I clinical study in dengue fever.

Turning now to our 87 and five two program.

Recently initiated a phase one clinical study and dengue fever.

Jean-Pierre Samadosi: Again, Janet will provide greater details on this program later in the call. In addition, over the last year, we have continued to advance our other programs and strengthen the Atea team as we move forward with late-stage development. Moving to slide five. As Andrea will discuss in further detail later in the call, we have an exceptionally strong balance sheet from which to support our clinical development programs. So the key value creation inflection.

Janet will provide greater details on this program later on the call.

In addition over the last year, we have continued to advance and with all the programs and training the entire team as we move forward with late stage to go off and.

Moving to slide five.

As on DRAM will discuss in further detail later on the call, we have and exceptionally strong balance sheet from which to support our clinical development programs.

So the key value, creating inflection points.

Jean-Pierre Samadosi: In addition to our crossover financing and our initial public offering during the first quarter, we also executed a significant collaboration with our partner Roche, a global powerhouse in antiviral development, manufacturing, and commercialization. With this strategic partnership, we received an upfront payment of $350 million. The agreement provides for joint global developments at a 50-50 co-sharing with Roche taking responsibility for global manufacturing. In addition to tiered royalties on net sales, there is potential for up to $330 million in development and regulatory milestones and an additional opportunity for up to $320 million for sales-based mouse.

In addition, two arm crossover and financing and that will initial public offering.

And squander, we also executed a significant collaboration with our palm though Wilkes.

Global powerhouse and empty of all day went up and manufacturing and commercialization.

With this strategy partnership we received an upfront payment of $350 million day.

The agreement provides towards drawing global demand trends on.

And that's a 50 50 cost sharing with Roche sticking with and somebody from global manufacturing.

In addition to chilled and wild views on that so there was potential for up to $330 million and development and regulatory milestones and then additional opportunity for up to $320 million for sales based milestones.

Jean-Pierre Samadosi: Let's now look at ways 8527, our lead candidate, may address the challenges that currently exist with the treatment and prevention of COVID-19. For the treatment of COVID-19, we believe that all direct acting antiviral, or DAA, Champlain, and the Central World Wildlife. The clinical benefit is to rapidly inhibit bio-replication in the early phase of infection and reduce disease progression, which will lead to a meaningful impact on global health.

Let's now look at ways eight new financing seven that will lead to on the Kansas. They may address the challenges that exist with the treatment and prevention of COVID-19.

On the treatment of COVID-19, we believe that oral direct acting antiviral or D A's share.

And play and the central role worthwhile.

Clinical benefit is to rapidly inhibit viral replication and the early phase of infection and reduce disease progression for which COVID-19 will lead to a meaningful impact on global health.

Jean-Pierre Samadosi: I believe that based on the 8527 DAA profile, it has the potential to reduce the transmission of the virus, prevent or shorten hospitalization, may be used in pre- and post-exposure prophylaxis, and hopefully have an impact on long-term COVID sequelae. We view the use of the DAA as complementary to the COVID vaccine and in a similar treatment paradigm to influenza where both vaccines and drugs are used concom VA is relatively easy and efficient.

We believe.

Based on these five to seven day, a profile has the potential to reduce the transmission of virus prevents of children hospitalization, maybe use and pre and post exposure prophylaxis and hopefully have an impact on long term probably its equivalent.

And we view the use of the D E. A S complementary to hobby and vaccines and.

And in a similar treatment paradigm to answer and so we're both vaccines and drugs I use concomitantly.

Yeah, it's a relatively easy choice and efficiently.

On manufacturer.

Jean-Pierre Samadosi: Manufacturer and Administrator. In contrast, antibody manufacturing in the administration may be complicated and costly, creating many challenges for healthcare. As expected, it was an irony run.

And administered.

In contrast, anti bodies manufacturing and the administration may be complicated and costly true.

And many challenges for the healthcare system.

As expected was on the island and the Raws, Toby and 19 variance on the book and the rapidly spreading globally and we see that impact.

Jean-Pierre Samadosi: COVID-19 Variants of the Mood are rapidly spreading globally, and we see the impact in the UK, Europe, South Africa, Brazil, and the United States. 8527 targets the SARS-CoV-2 RNA polymerase, a highly conserved, non-structural protein that is also called NSP12, which is responsible for both viral RNA replication and transcription. Given this preferential conserved target, it is anticipated that Atea 527 will maintain its antiviral activity even against the recently emerging variants with mutations in the spike protein responsible for receptor recognition and the host cell membrane fusion process. Moving to slide eight.

And the U K, Europe, South Africa, Brazil, and the United States.

85 to seven targets, the Sars Cov, two island and polymerize.

Highly conserved non structural protein she's on Socal and lets speak 12, which is responsible for both volume and I'm, a navy pancakes and and transcription.

Given this preferential confirmed target it is anticipated that 85 to seven will maintain he sent you on activity even against the recency emerging variance with mutations in the spike protein responsible for the receptor.

The recognition and the wholesale named Wayne fusion process.

Moving to slide eight.

Jean-Pierre Samadosi: 8527, as we have mentioned previously, targets the RNA polymerase and essential, Unknown Speaker, Unknown Speaker. This irony polymerase has two functional domains. Beside the RDRP, which is the well-known catalytic subunit incorporating nucleotides into RNA templates, there is also an N-terminal domain called NIRAN, which has a GDP binding pocket with nucleotidial transfer activity, Recently, we obtained a 2.98 atomic structure of the quaternary complex, including Nsp12, its cofactors Nsp7 and Nsp8, an RNA template, and AT9010, the active triphosphate metabolite of AT527.

85 to seven and as we've mentioned previously.

And I'll get the RNA polymerase and essential.

Volume with vacation.

This and when they put them on ways to functional domains.

Beside the Aldi L P, which is the well known catalysis subunit, incorporating nuclear tied to island and the template.

There was also and terminal domain on Iran.

Which has a G E b finding pockets with net royalty deal transforming its activity, but is biological function was largely and known until now.

Recently.

We obtained a 298 am strength.

Cryo electron microscopy structure on the quarter on really complex, including and that's B 12, It's cool factors and that's B seven.

And and that's B eight.

And Avenue template.

And 18 90 10.

Keep try and phosphate metabolites of 85 to seven.

What is really interesting is that we sold 318 90 10 molecules binding two D and that's B 12.

Jean-Pierre Samadosi: What is really interesting is that we saw three 18910 molecules binding to NSB-12. Two of them are located in the RDRP active site, and one is incorporated into the Ionate template, while the second is installed at the pre-incorporation state, very likely causing chain termination. Furthermore, a CERN 18910 molecule binds to the NIRAN active site. Unknown Speaker 0, To our knowledge, this is the first time ever.

Two of them are located in the RV on P active sites.

And one is incorporated.

And to the island and templates.

The second is stalled on the free incorporation state.

They liked and eat closing changed I mean Asia.

More importantly, our search.

18, 90, 10 molecules bind to the new brands active site.

Walking its function.

Well and knowledge. This is the first time ever.

Jean-Pierre Samadosi: A description of an inhibitor binding to Niran has been elucidated. Now, since we know exactly how the compound 18-90-10 interacts with these two binding sites. It will help us to design potentially even better inhibitors in our next generation product. We believe that the dual mechanisms of 8B527 are highly important as an anti-viral because, in collaboration with Dr. Bruno Cunard, who is a work..., renowned exponent of viral irony, Whippy Cakes. We recently discovered that there are actually two distinct paths, and an independent way by which SARS-CoV-2 initiates RNA synthesis for the new RAM-dependent pathway.

On a description of the and the inhibitor binding to new and has been and to date.

And now since we know exactly all the compounds 18, 19 and interacts with these two binding pockets it will help us.

The design and potentially even better inhibitors and that.

And next generation programs.

We believe that this dual mechanisms of 85 to seven.

Highly important and anti viral because and collaboration loosen the peanuts.

Luisa would.

Renowned experts on violet and when he would be cases.

We recently had this call with the actually two distinct pathway.

And he ran dependence and.

And and independence by which songs goes to initiate I wouldn't a synthesis.

For the new Ram dependent and passed away.

Black and.

And this.

So from the knee ran dependant pathway, the NSP 12, new brands.

Jean-Pierre Samadosi: The end. [inaudible] The NSP-12 NIRAN, can label. The NSBA cofactor was a nucleotide, preferably UMP, which then served as the primer to initiate the myelinous strand RNA centrifuge. This is called protein-prime RNA synthesis, which was described previously only for piconucleobaric cells. This is the first demonstration that Coronavirus NIRAM also has a similar function, and our product candidate, so its binding to the new ramp, is expected to block this function. The second password is niranindependent, where the RDRP can synthesize a dinucleotide which then serves as the primer to initiate RNA synthesis.

Can label.

And SBA cofactor was a nucleotide.

Preferably you M P.

And then so I was to try and though to initiate the mine and the strength and a synthesis.

This is called proteins crime and when they synthesis, which was described previously only focused on the boxes.

This is the first demonstration.

That.

Corona virus and he ran also a similar function.

And I won't go on candidates should we binding to the new brand is expected to block dysfunction.

The second pathway is new and independent where the all the ERP consensus size Dinucleotide, which then serves as the prime book to initiate island and they synthesis.

Jean-Pierre Samadosi: Our product candidate can also block this fund. We believe that this unique dual mechanism of inhibiting both the neuron and RDRP with our product candidate can potentially give us a differentiated advantage in terms of creating a high variant resistance and providing broad antiviral coverage to different variants. With that overview, I will now turn the call over to Janet for a more in-depth clinical development update.

Our product candidates and also block dysfunction.

We believe this unique dual mechanism of inhibiting both the new round and of the ERP was our product candidate can potentially give us and <unk>.

And any changes and vintage in terms of creating a high barrier to resistance and providing broad, hence eval college to different variance.

With that overview I will.

I'll now turn the call over to Janet for a more in depth clinical people often updates.

Thank you Sean.

Janet M. J. Hammond: As we have just mentioned, COVID-19 variants have emerged and are rapidly spreading globally. We believe that a multi-pronged approach, including both prevention and treatment, will be essential for the challenges that we will continue to face with this virus. With the emerging variants, unfortunately, there is variable efficacy of the vaccines, and it seems that this will likely prolong the pandemic. Also, there is considerable disparity in vaccine access and uptake in various regions, so the vast majority of the population is still unprotected.

And just mentioned COVID-19 day haven't matched.

And just spreading globally.

We believe that's on multi pronged approach trading day.

Okay.

Libya from sort of a true.

LNG stuff and they'll continue.

And the songs.

With me on matching buyers and unfortunately.

Oh boy.

And so on.

And it seems that that's a likely prolonged.

Also varies from quarter little clarity and boxing.

And that's taking Paris region.

And the vast majority of the population still on Talktalk.

Janet M. J. Hammond: Furthermore, there are, if necessary, many different vaccines being rolled out simultaneously, and the efficacy and spectrum of protection differs between them, adding a further layer of uncertainty around who is protected and under what circumstances. A likely future scenario would be the need for booster shots, for Antibody Treatment; we have already seen the efficacy decrease in the face of the new variant. As Jean-Pierre mentioned, since 18527 targets highly conserved viral polyme

Furthermore.

And many different zoster and being rolled out simultaneously and.

First from a protection this is between them.

And the father, Marvin Samson came along and she was put on close and handoff talk from funds.

And likely future scenario, where people need a place to shop.

And so about each week when do we have already seen efficacy day.

On your phone.

And I'll jump on that.

Okay, five seven impossible how is from southpaw.

We anticipate that the 85 to seven will retain its antiviral activity even in the presence of volume.

Janet M. J. Hammond: We anticipate that A2527 will retain its antiviral activity even in the presence of variants, and vaccines will play an important role in controlling the COVID-19 pandemic. We clearly are going to need additional treatment options to stay ahead of the virus, and direct acting antivirals will be an essential complement to vaccines in the evolving treatment paradigm. As summarized on slide 12, 2021 is expected to be an eventful year for 8527, as highlighted by the multiple global clinical trials we plan to conduct with our partner, Roos. Throughout 2021 and beyond, we will be delivering a series of daily readouts that will form our roadmap to a near-term NDA submission and product loan.

Those things are playing important flow little true filing.

And the Kansas and.

We clearly are going to need additional treatment options.

Goodbye.

And I'll talk to launch of ours will be an essential come from them.

Okay.

Sure.

On slide 12.

Thank you Wang is expected to be on the phone call off 85 from suffering.

As highlighted by the multiple global clinical trials with plans to conduct your top half day bench.

So I'll try and to 'twenty, one I'm, sorry on what you'll be delivering a series of both leap off of.

That's the full malware from yes from India.

Admission and product launch.

Janet M. J. Hammond: We expect virology data from the two ongoing phase two studies in the second quarter, and we expect the Global Phase 3 program with Roche to be initiated in the second quarter. On slide 13, for COVID-19, a regimen of 8527, 550 mg twice daily, or BID, was selected as this dosing rate scheme is predicted to achieve high and sustained intracellular active triphosphate levels rapidly in both the lungs and the respiratory tract, which is what is needed to inhibit SARS-CoV-2 replication.

We expect on I'll, let you guys go from the two ongoing phase two studies and a couple of quarters.

Uh huh.

And we expect the global Phase three program with range to be initiated in second quarter.

On slide 13 from perfect 19, a regimen of 85 to seven and 550 milligrams twice daily.

And what's the law.

Based on rate schemes.

To achieve high and sustained interest colon cancer.

Jeff I'll take Nicolas Rocketing.

And both the lung and liver cirrhosis trial, which is closer to need to pull the cost.

K V two rockets of awesome.

Absolutely and as a PK profiles using data from previously completed clinical trials.

Janet M. J. Hammond: Our simulated PK profiles using data from previously completed clinical trials were recently published in Antimicrobial Agents and Chemotherapy. We conducted a Phase 1 study to assess the safety and intensity of the 550 mg BID regimen administered for 5 days to 20 subjects, randomized equally to drug or procedure, in December. The top-line results from the study demonstrated that AIDS B527 was safe and well tolerated in healthy participants at the treatment dose envisaged for COVID-19, and these results were presented at COI earlier this month.

And quick published and lunch microwave and agent from chemotherapy.

We conducted a phase one study to assess the safety and PK of the fastest and major crime Tid regimen.

And I missed a per cycle.

And two subjects randomized equally strength.

And with a simple.

The topline results from this study demonstrates and across 85 through seven was safe and well tolerated and healthy participants.

Based on the pontoon.

And the interest.

About what percentage of crime Uh huh.

Janet M. J. Hammond: We're continuing to make progress with the ongoing phase two study in hospitalized patients. Enrollment continues, and we expect to report interim virology data on a meaningful number of patients from the study during the second quarter. But I want to point out that this is not a pre-specified analysis.

We are continuing to make progress with the ongoing phase two study and my person.

Person.

Weldment continues and we expect to report interim biological from on.

On a meaningful number of patients from the study during the second quarter and.

I want to point out that this is not a prespecified and Tyler.

As previously mentioned this is a phase two proof.

Janet M. J. Hammond: As previously mentioned, this is a Phase II proof-of-concept study and is not statistically powered. We consider this Phase 2 trial to be a study where we will be able to obtain proof of concept for dose selection for antiviral efficacy and also, and most importantly, confirm the safety profile of the drug, which was the main reason for selecting a hospitalized patient population initially. The continuing support of data for safety and tolerability will allow us to continue to move forward in the outpatient sector, which is where we anticipate the majority of the drug will be.

Proof of concept study and does not statistical part.

We concluded the phase two trial and study.

We will be able to obtain proof of concept for dose selection and trial efficacy.

And also and most importantly confirm the safety profile of the drug which was the main reason for selecting.

Patient population initially.

The continuing supposed to close at the safety and Tolerability with allow us to continue to move forward and the outflows from Costco.

Which is probably anticipate I'll sneak on much hours and is attractive.

And so far.

Janet M. J. Hammond: The intensive virology study currently being conducted by our partner, Roche, is evaluating the same outpatient population that the phase three protocol will study. There are currently sites in the UK, Ireland, Spain, Bulgaria, and Belgium, and more sites are continuing to open.

Apologies, Bobby principal and conducted by our partner Roche.

Well the same patient population and about the phase three protocol sales forces.

So all kinds of sites and the U K.

And.

And Bulgaria, Belgium, and more five blocks and some of them.

This study is evaluating safety and pharmacokinetics and pharmacodynamics.

Janet M. J. Hammond: This study is evaluating safety, pharmacokinetics, and pharmacodynamics, as well as the antiviral activity of AC527 compared to placebo in up to 220 patients. We expect interim virology data from the study on a meaningful number of patients during the second quarter. And again, as I say, two studies, this is not statistically powered, on slide 16.

That's one of the antiviral activity of 85 to seven.

Hard to placebo and up to 200 and trying to paulson.

We expect interim virology days on the study on a meaningful number of patients during the second quarter.

And then is it safe to study this is not just to keep hot.

On slide 16.

Janet M. J. Hammond: The Global Phase 3 trial will evaluate efficacy and safety again in the outpatient setting. We have received positive feedback on the trial design from the EMA, and we are in active dialogue with the FDA about the design of this trial. We anticipate that Roche will initiate this program in Europe in the second quarter. Now, to our Thank You Fever program. If it wasn't for the COVID-19 pandemic, we would very likely be discussing outbreaks of dengue fever, as we see this as a very impactful and yet unaddressed medical need.

The global Phase III trial will evaluate the efficacy and safety again and the allocation cellphone.

We have received positive feedback on the child's Wang from EMEA.

And we are and after dialogue with the FDA profit wrong at this point from where.

We anticipate that first for an initial program in Europe, and the second quarter.

Moving now to I think you see for Satcom.

And if it wasn't for COVID-19.

And I think we would very likely be discussing outbreaks with dengue fever and said this is a very impactful and just on the day medical needs.

Janet M. J. Hammond: There are currently no active treatments available for dengue, and management consists of supportive care only. This is a mosquito-borne viral disease, and almost 400 million individuals are affected annually. Approximately 500,000 people will develop haemorrhagic fever with a mortality rate of 2-3%. This flavivirus disease is endemic in Southeast Asia, South America, the Caribbean, and is increasingly encroaching into the southern United States. Our breakthrough drug candidate, AT752, is a purine nucleotide prodrug with potent in vitro activity against all serotypes tested, as well as against other major flaviviruses.

There are currently no applications available for dengue and management and systems Post Cat, England.

This is a mosquito borne virus.

And there are almost 400 million individuals across the army.

Approximately 500 calls from people well developing electric fever.

And we'll pause you range of two to true.

This places our diseases and stomach and coffee Asia, South America, the Caribbean and increasingly is encroaching on just the problem and you know but.

And our breakthrough drug plan to this 87 and five to repairing you kick off contract with persons in vitro activity against all share type stuff.

And as well as against other nature from major changes awesome.

Janet M. J. Hammond: We've demonstrated perfect efficacy and excellent tolerability in a small animal model in our preclinical toxicology study. Consistent with our guidance in December, we filed a CTA in Australia and initiated a Phase 1A study in healthy volunteers this March. The Phase 1a study will be followed by a Phase 1b proof of concept study in adult dengue patients in Southeast Asia. Before turning the call over to Andrea, I'd like to point out that Atea's clinical development program is robust and encompasses early through late-stage studies with a steady flow of data readout.

We have demonstrated potent efficacy and excellent tolerability and small animal model and our preclinical toxicology studies.

Consistent with our guidance in December we filed the Cta and Australia and initiated a phase <unk> study in healthy falls and chest as much.

The third one is that he will be followed by today's Wednesday proof of concept study and at all thank you patients from classes falls on.

Before turning the call over to Alan Graf.

Nope, that's past clinical development program is robust and and campuses are these two late stage studies with a status with Dolce Vita.

Importantly on nucleotide congrats platform has potential against a broad array of other viral infections, including yesterday, I think just like ours and stuff the corona virus and pages are responsive.

Janet M. J. Hammond: Importantly, our Nucleotide ProGrad platform has potential against a broad array of other viral infections, including yet to be identified viruses of the coronavirus and plague virus families. As a physician-scientist, this is a true privilege to be working on delivering potentially life-saving oral antivirals to patients with limited treatment options. With that, I will now turn the call over to Andrea for a review of the scenario.

And the physician scientist this is a true privilege to be watching on delivering potentially lifesaving antivirals to patients with limited treatment options.

With that I'll now turn the call over to on graph for you for free.

And Sean.

Thank you Janet.

Andrea J. Corcoran: As Jonae mentioned in her introductory remarks, earlier today, we issued a press release containing our financial results for the full year 2020. For 2020, our research and development costs mainly reflect the AT527 Clinical Development Program costs related to the advancement of AT527 from IND to late-stage testing for COVID-19. Our general and administrative expenses are primarily driven by the growth of our organization through the expansion of personnel across several key functions.

SG&A mentioned in her introductory remarks earlier today, we issued a press release containing our financial results for the full year 'twenty 'twenty.

For 2020, our research and development costs, mainly reflect the 85 to seven clinical development program costs related to the advancement of 85 to seven from I N G to late stage testing for COVID-19.

Our general and administrative expenses are primarily driven by the growth of our organization through the expansion of personnel across several key functions.

On slide 21, I am pleased to report that we ended 2020 with an exceptionally strong balance sheet to support our clinical development programs and business activities.

Andrea J. Corcoran: On slide 21, I am pleased to report that we ended 2020 with an exceptionally strong balance sheet to support our clinical development programs and business activities. In addition to our crossover financing of $215 million and the net proceeds from our initial public offering in the amount of $317.6 million, during the fourth quarter of 2020, we also executed the collaboration with Roche, pursuant to which we received an upfront payment of $350 million. As a result, as of December 31, 2020, cash and cash equivalents were $850.1 million. Our current cash runway takes us through 2023. I'll now turn the call back over to Jean-Pierre for his closing remarks.

In addition to our crossover financing of $215 million and the net proceeds from our initial public offering and the amount of $317 6 million.

During the fourth quarter of 2020, we also executed six collaboration with Roche pursuant to which we received an upfront payment of $315 million.

As a result.

And that's December 31, 'twenty, and 'twenty cash and cash equivalents were $851 million.

Our current cash runway takes us through 2020 three.

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

Jean-Pierre Samadosi: Thank you, Andrea. These are exciting times for Atea, and we are very proud of the important progress we have made and the contribution we expect to make in fighting COVID-19. We look forward to sharing data on the two Phase II clinical trials in the near term and the initiation of the Phase III program. As most of you know, moving from IND to potential product launch in less than two years for a DAA small molecule is a Herculean effort before opening the call to your questions.

You enjoy them.

These are exciting times, let's say on and we're very proud of the important progress we have made and the contribution we expect to make and fighting COVID-19.

We look forward to sharing data on the two phase III clinical trials and the near term and the initiation of the phase III program.

As most of you know moving from IMD to potential project lunch and less than two years for a D. A a small molecule is on the herculean and therefore efforts.

Before opening the call to your questions.

Jean-Pierre Samadosi: I would like to take this opportunity to express my gratitude to the exceptional Atea team, our strategic partner Roche, the researchers, the physicians, and the patients who support our clinical and regulatory advances. Without their collaboration and support, we would not have achieved the accelerated progress we have made today. With that, Operator, we will now open the call to your questions.

I would like to take this opportunity to express my gratitude to the exceptional and sales team.

Strategic bond and Roche and we show it shows the physicians and the patients supporting our clinical and regulatory advancement.

Resolve that collaboration and support.

And not have achieved the accelerated progress we have made to date.

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

Thank you if you have a question at this time. Please press star and then the number one key on your Touchtone telephone. If a question has been answered or you wish to remove yourself from the queue. Please press the pound key please standby and will all be compile the Q&A roster.

Operator: Thank you. If you have a question at this time, please press the star and then the number one key on your touchtone telephone. If your question has been answered or you wish to remove yourself from the queue, please press the pound key. Please stand by while we compile the Q&A roster. Your first question comes from the line of Eric Joseph with J.P. Morgan. Your line is open.

Your first question comes from the lineup Eric Joseph with JP Morgan Your line is open.

Eric William Joseph: Good evening. Thanks for taking the questions. A few from us.

Good evening, thanks for taking the questions.

A few from us.

Eric William Joseph: First, in looking to the interim virology data from the phase two trials next quarter, could you set the stage there a little bit with respect to how frequently you're sampling viral load? What would be viewed as a meaningful reduction? Are you also looking at viral clearance? And then to what extent are you also going to be looking at COVID physiopathology and a couple of follow-ups. Thank you.

First and looking to the interim by our virology data from the Phase II trials next quarter could you set the stage there a little bit with respect to.

And how frequently you are sampling viral load would be viewed as a meaningful reduction are you also looking at.

Are you looking at viral clearance and then to what extent are you also thinking about the COVID-19 visit mythology.

On a couple of follow ups.

Janet M. J. Hammond: Thank you, Eric, for the question. Janet?

On the question Janet.

And weather.

And the style and networks in terms of and something obviously at the entry to the study and.

Janet M. J. Hammond: So, Eric, we're looking at viral kinetics in terms of sampling, obviously, at entry into the study and then on day one, day two, day five, day eight, day 10, and day 14, so we should have a reasonable scatter and should be able to see good viral kinetics because we are obtaining frequent samples. And then with regard to, I'm sorry, I think I'm forgetting the rest of your question. If you wouldn't mind repeating it,

And then on day.

Well one day two day five day eight day 10 and day 14, So we should have a reasonable gotcha and.

Should be able to see could draw from that.

Because we off on a per.

Many quickbooks on pulp.

And then.

And two I'm, sorry, I think I forgot the rest of your question if you wouldn't mind completion.

Are you interested in.

Eric William Joseph: Are you interested in seeing viral clearance or just looking at viral reduction? And, I guess, are you also able to gather information with respect to symptomatology or symptom reduction?

Seeing viral clearance or just looking at viral reduction.

And I guess are you also able to gather information with the sector.

Symptomatology or symptom or Gucci.

So we have to keep our parents as well as all of the vaccine and on what window from Sabra and.

Janet M. J. Hammond: So we hope to see viral clearance as well as viral reduction, and we're looking for that. Symptoms are also being collected, but the symptoms are not being self-reported. They're being collected by the investigator.

Okay.

And I'll also being collected on the symptom.

And so nothing self reported that being collected by the investigator and.

So we and that we.

We expect we will have and information on from production from.

Eric William Joseph: Okay, got it. And with respect to the drug-drug interaction trial, can you just walk us through what FDA, what regulators, are interested in seeing their, particularly with the crossover study with Parva Mez's team, just what's the rationale for looking at how AT517 interacts with that compound? What's it a stand-in for? I see what's standing in front of me, I stand in front of it.

Okay got it and.

With respect to the.

The drug drug interaction styles.

Can you just walk us through what FDA, what regulators are interested in seeing there.

And particularly with the crossover study with carbon measured team.

And what's the rationale for looking at.

And how 85, one standard interacts with that compound what's the day.

Our standard for.

I've seen them extending.

And for some time.

Pharmacology.

Pharmacy and the population thanks.

Well I think and.

Janet M. J. Hammond: Well, I think the DDI studies are really pretty much the routine DDI studies that you would anticipate for any regulatory package in anticipation of an NDA submission. And as a nucleotide, we don't anticipate that the drug interaction profile is going to be all that unusual and rather similar to some of the other nucleotide drugs that one is already familiar with. With regard to the carbamazepine study, we know that 8527 is a PGP, has some PGP interactions, and so carbamazepine is being evaluated here because it is a potent PGP inducer, and potentially one might need to dose higher doses of 8527 in combination with carbamazepine.

So the the dji studies already pretty much and the routine DDI studies that you would anticipate Randy for any break and exit package and.

And anticipation of an NDA submission.

And as a nucleoside and.

We don't anticipate that the drug interaction profile and it's going to be and.

All of that's unusual and and rather similar to some of the other niches hydraulics that when they've already familiar with with regard to the carbamazepine study.

We know that and.

Eight to five to seven is a P. G P.

I heard from PGP and and.

Interaction and so carbamazepine and thing.

And evaluate carbon and that seems a potent PGP and Jupiter and potentially on nicely Tuesdays at higher doses, almost 85 to seven and combination with carbamazepine and of course with her disease, such as COVID-19, we're anticipating a broad range of patients who match.

Janet M. J. Hammond: And of course, with a disease such as COVID-19, we're anticipating a broad array of patients who might need to receive this drug. And so, in some ways, it's not a target for anything but really an important aspect of understanding how to administer the drug to patients with epilepsy and other such diseases. Okay, great. Thanks.

Need to receive the strength and sorry income range targets or anything, but really and importance.

And understanding how to administer the drug to patients with epilepsy and and other types of diseases.

Okay, great. Thanks, Thanks, so on so much for taking the questions and I'll hop back from here.

Eric William Joseph: Okay, great. Thanks. Thanks so much for taking the questions. I'll hop back in here.

Okay.

Sure.

Your next question comes from the line of Matthew Harrison with Morgan Stanley. Your line is open.

Operator: Your next question comes from the line of Matthew Harrison with Morgan Stanley. Your line is open.

Jonathan Miller: Hello, this is Jonathan from Matthew. Thank you for taking the questions.

Hello. This is Joe on for Matthew Thank you for taking the question.

Jonathan Miller: Congratulations on the progress. I have two questions. The first one is, what is the current enrollment status for COVID phase 2?

On the progress I have two questions the first of all.

How is the current enrollment and statements with the Covid. The phase two study in hospitalized setting and the second and why is the same study would you expect to see any.

unknown: [inaudible]

unknown: In the same study, would you expect to see any improvement?

unknown: Improvement in clinical markers

Improvement in clinical markers.

John.

And then.

Janet M. J. Hammond: So the enrollment continues, and we are slowly enrolling patients into the study. I would say that enrollment has been challenging for a number of reasons, some of which we've mentioned before, but really just to highlight for you the fact that the patient population that we're attempting to enroll is a patient population with moderate COVID-19 who require hospitalization but who don't require mechanical or very active support of ventilation. So they're required to need to be hospitalized and potentially require oxygen support with nasal cannulae only to qualify for the study. And then the idea is really for the primary endpoint to measure progression from that point or lack thereof.

And 10 years, and we and all.

Clearly inverted and comes from going to the study I would suppose upbeat and Goldman has been challenging.

So a number of reasons.

Some of which we've mentioned before but really just to highlight the fact that the patient population that we're attempting to anvil.

Patient population with moderate terrific momentum.

Who require hospitalization, but free cash for call and mechanical or very active support of inflation and so they're a class two and mitsui hospitalized and sequentially two o'clock and propose with nasal upon really only to qualify for the study and then.

And on the idea is really for the program to measure progression from that point or lack thereof.

Janet M. J. Hammond: But in the face of a surge of COVID-19, the patient population doesn't really exist in the hospitalized session for the most part, because patients need to be considerably fitter than this to be enrolled and admitted to hospital. So that has really made it quite challenging to find these patients and the window in the COVID-19 pandemic when such patients are eligible for admission to hospital. And nevertheless, we continue to enroll patients.

And the.

Both of the sort of COVID-19, and special populations doesn't really exist and the hospital.

Hospital patient needs to be considered the stickers on it.

To be enrolled on treatments to hospitals, there and.

And that is ready and made it challenging to find.

Find these patients and and and.

The windows and the Covid pandemic bring such patients are eligible for clinicians and hospital and Nevertheless, we continue to enroll patients. However, hum, let's say in the United States, particularly also because of the changes and the standard just cash that has particularly impacted treatment and the United States and have proven a friend does yeah on the.

Janet M. J. Hammond: However, perhaps less so in the United States, particularly because of changes in the standard of care that have particularly impacted treatment in the United States with the approval of Remdesivir and the antibodies. These are less accessible outside of the United States, which makes it a little easier there.

Antibody.

These non-GAAP op festival outside of the United States, which muscle skeletal Eva and nevertheless.

Janet M. J. Hammond: Nevertheless, enrollment is slow, but we continue to persevere with it. And with regard to the symptoms, yes, we are collecting clinical symptoms improvement by the investigator as they observe the patients during treatment. So we will have information on that.

And clearer on that day.

That does conclude possibly out with it and and.

With regards to the symptoms, yes, we all connecting them.

Clinical symptom improvement and.

<unk> and basketball.

That's true.

And we'll have most of them on.

Okay.

Yes.

Got it and thanks, and how about the second question on any do you see any clinical markers improvement.

Jonathan Miller: Got it, thanks. And how about the second question? Do you see any clinical markers or improvements?

unknown: Co-markers, and improvements from the study.

From the study.

So it would be.

Janet M. J. Hammond: So we will have, as I mentioned, clinical symptom improvement, but the study is ongoing and remains blinded. So I can't, I don't have any information on clinical symptom improvement at the moment. Okay, thank you very much. Your next question comes from the line of John Miller with Evercore ISI. Your line is open.

We will have we will have as I mentioned, the clinical symptom improvement that the study is ongoing and remains behind it. So I can't I don't have any information around and chemicals.

Chemical tanker and improvements at the name.

Okay. Thank you very much.

Thank you.

Your next question comes from the line of Jon Miller with Evercore ISI. Your line is open.

Operator: Thanks for taking the question, guys. I think just a follow-up to that previous one; I understand that enrollment has been challenging for the Phase IIs in the past. Can you talk a little bit about how you're adapting your strategy going forward into Phase III and what the push-pulls are on enrollment timelines and readout timelines as we look at Phase III?

Thanks for taking the question guys I think just a follow up to that previous one I understand that enrollment has been challenging for the phase twos and the past can you talk a little bit about how you're adapting your strategy going forward into the phase three and what the push pulls are on enrollment timelines and readout timelines as we look at phase III.

Janet M. J. Hammond: So really, essentially, what we're doing is trying to have as comprehensive a list of sites around the world in anticipation of the pandemic moving from place to place, because one's got to be one step ahead of the ball all of the time. And really, I think that is the best strategy that we have been able to come up with. We hope that the outpatient studies will be somewhat easier to enroll because there won't be these requirements for hospitalization, which have really put, I think, a filter on what we've been able to do with that study.

And if he wants.

Really essentially what we're doing is trying to have as comprehensive and.

Just a site and around the world.

And anticipation of the pandemic moving from place to place because one supposed to be one step ahead of the poll on all of the time and.

Randy I think that's the best strategy that we have been able to come up with.

That's the outpace on studies will be somewhat easier trimble, because there aren't going to be easy and.

Tom and Paul hospitalization to trucks, and Randy's put us I think a filter on what he's been able to do it with that study, but and we are all set for pads and the fact that I think this is also going to be challenging and we have we have really tried to them through.

Janet M. J. Hammond: But we are also prepared for the fact that I think this is also going to be challenging, and we have really tried to spread the net as widely as we can to have as many sites as possible. Excellent. Thank you.

Through the net is widely at this time too and have as many sites as possible.

Excellent. Thank you and I suppose one more follow up on mechanism and J P. I know you've you've both hit a multiple times. The fact that our DRP is highly from chip protein and dual mechanism of action might help you prevents viral escape from that but in Europe.

unknown: I suppose one more follow-up on mechanism. JP, I know you've both hit on multiple times the fact that RDRP is a highly conservative approach.

unknown: [inaudible]

Frequent understood just on it.

unknown: Unknown Attendee, Jonathan Miller, Unknown Attendee, Jonathan Miller, Unknown Attendee

Finer point on it and your preclinical work thus far have you observed viral escape mutations day against that and 27 in general and and if so how would you characterize the mutant.

unknown: and their likelihood of popping up in the real world.

And their likelihood of popping up on the real world.

Jean-Pierre Samadosi: Nice. It's a good question, John.

No. It's a good question John and.

Jean-Pierre Samadosi: And we are looking at right now. So, right now, we have two important in-vitro studies ongoing. One is to see if we can generate resistant mutants. As you know, it will be very difficult to do that in SARS-CoV-2 infected cells. That's why we are doing that at Utah State, the NIAID contractor with HUH7 cells infected with OC43, which is a human season of coronavirus, as you know, which is also a beta coronavirus.

We are looking at right now so right now we are too.

Importantly, our in vitro studies ongoing one is to see if we can generate a resistant mutants and as you know it will be very difficult to do that are in and some scope to our in fact it sounds that's why we are doing that and youth.

State on DNI and your contract with.

And the HOA seven cells incited with Oc pool destroy and we choose a human season on the go Nobody's. Besides you know which is also a.

Better cool and move on us and stuff.

Jean-Pierre Samadosi: So those studies are ongoing. Definitely, in the next couple of months, we should have the data. Now, and you can check the manuscript on BioXRF, you can see that we have a very good knowledge of all the amino acids where we have the binding, both in the NIRAND and the LDRP.

And so those studies are ongoing.

It's in the next couple of months, we should have the data no sugar and you can check the manuscript on by lifestyle.

You can see that we have very good knowledge of all the amino acids are what we have the binding on.

Both AR and the new brand and D. L. D. B and then lastly, we on and that's the gating and also and as they are available.

Jean-Pierre Samadosi: And then lastly, we are investigating, as they are available, the UK, the South African, and the Brazilian variants as we speak as well. So we will have data in contrast to antibodies where you can use a surrogate virus. Here we have to use a live virus, as you know, to evaluate them in those assays. So that is ongoing, and I'm sure that on the next call, we will have the data to share with you. Okay.

And the UK, the south Africans, and and and and the Brazilians variance on as.

As we speak as well so we will have data and in contrast to antibodies, where you can use a a a a so a good balance here we have to use a live on it. It says you know.

unknown: Okay, thank you very much. I look forward to seeing you.

To evaluate those and those assets so that is ongoing and I'm sure that at the next call. We will have good data to share with you.

Operator: Your next question comes from the line of Tim Lugo with William Blair. Your line is open. Hey, this is Locke going on for Tim. Thanks for taking the time.

Okay. Thank you very much look forward to seeing that.

Yeah.

Your next question comes from the line of Teen Lugo with William Blair. Your line is open.

Hey, this is lachlan on for Tim Thanks for taking the questions.

unknown: Hey, this is Lachlan speaking for Tim. Thanks for taking the questions. So I had a couple. I guess first of all, as it relates to the, you know, phase two trial, have you seen any sort of new safety signals at the BID dose that you didn't see at the, you know, the QD that you used previously? And then, and second of all, I noticed that you're expanding the intense virology study sort of geographically. Is there, you know, rationale for that beyond? Accelerating Enrollment

And I had a couple I guess first of all as it relates to the.

And the phase two trial.

Have you seen any sort of new safety signals and the B I D does that you didn't see at the.

Our acute data you used previously.

And then and second of all I noticed that you're expanding the.

And it tends to virology study.

Sort of geographically.

Is there a rationale for that and beyond just are you accelerating enrollment.

Janet M. J. Hammond: So your second question, you know, we're expanding the study really to ensure that we're able to enroll it as expeditiously as possible. And there is no other rationale behind that. And I'm sorry, and what was your first question?

Yeah.

Got it.

So they will put you.

Your second question.

And we're expanding the study ready to ensure that we're able to and wrote us as expeditiously.

As possible and.

And and and there is no no other rationale.

Behind that and.

And I'm, sorry, and and your first question was.

unknown: [inaudible] An unknown Speaker.

And so that's about safely.

Janet M. J. Hammond: The safety profile has been similar to what we encountered with the 550 mg once daily. Safety continues to be very, and it seems to be safe and well-tolerated. We've had two DSMBs. The second one was in December, but we've continued to enroll patients subsequent to that, and there have been no serious adverse events which have been considered drug-related.

And so that then it has been that the safety profile has Hudson and.

And if you want to see and.

Contract, what's the fastest and milligrams once ago.

Close to continues to be very simple safe and well tolerated we have to the F&B and the second one was in December.

We continue to enroll patients subsequent to that and nothing more.

And I thought that the from and which are inclusive of practical clinical safety and tolerability quickly to be on site.

Janet M. J. Hammond: So the safety and tolerability continue to be very pleasing to see. Great, thanks. There are no further questions at this time. I would like to turn the call back over to Speaker Jim Pearson-Medoci for closing remarks. Go ahead, sir. Thank you again for joining us, and thank you for your continued support of Atea. Thank you. This concludes today's conference. Thank you for your participation, and have a wonderful day. You may all disconnect.

Cool.

Great. Thanks.

There are no further questions at this time I would like to turn the call back over to speak on some of those he for closing remarks and go ahead Sir.

Thank you again for joining us and thank you for your continued support of fatigue and thank you.

This concludes today's conference. Thank you for your participation and have a wonderful day you may all disconnect.

Operator: BF-WATCH TV 2021

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