Q3 2022 Atea Pharmaceuticals Inc Earnings Call

November 7, 2022

Okay.

We are now live.

Good afternoon, ladies and gentlemen, welcome to the Otter tail Pharmaceuticals third quarter 2022 financial results and business update conference call. At this time all participants are in a listen only mode follow before following the formal remarks, we will open up.

The call for your questions.

In order to ask a question please.

One on your telephone keypad I will now turn the call over to Jay Barth Senior Vice President of Investor Relations and corporate communications at a tier pharmaceutical Ms. Barnes. Please proceed.

Thank you operator, good afternoon, everyone and welcome to Acadia Pharmaceuticals third quarter 2022 financial results and business update conference call earlier today, we issued a press release, which outlines the topics we plan to the Scott you can access the press release as well as the slides that we'll be reviewing today by going to the.

The investors section of our website at IR retire pharma dot com.

With me today from Matteo <unk>, our Chief Executive Officer, and founder Dr. John <unk>, Chief Development Officer, Dr. Janet Hammond, Chief Financial Officer, and Executive Vice President of legal and three a Cork, Brian and our Chief commercial officer jobs every call. They will all be available for the Q&A portion of today's call.

Before we begin the call that's outlined on slide two I would like to remind you that today's discussion will contain forward looking statements that involves 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.

Curiously from what is discussed on today's call.

With that I'll now turn the call over to John here.

Thank you Tom and.

Good afternoon, everyone and thank you for joining us.

A number of updates to review with you today demonstrate the considerable progress we have.

So far this year across our three clinical programs.

Turning to slide four.

As we assessed as a COVID-19 landscape.

The rapid increase in dominance of multiple new variance in different regions of the world.

Combined with social dynamics.

Back to near pre pandemic norms.

Neologize.

COVID-19 will persist with multiple wave as we currently see today.

They're wanting to do it below the associated with vaccines.

And natural infection.

And the low uptake in the number of people receiving their own <unk>.

Mr vaccine with only less than 10% in the U S. Currently.

We continue to close large numbers of infected individuals and reinforce the need for new direct acting antiviral.

Looking forward as well.

We start enrollment of Sunrise.

Our global Phase III Registrational trial.

Growing waves with variance not susceptible to currently available preventive tools shouldn't enable timely enrollment of patients for this trial.

Pandemic COVID-19 waste can be life threatening to dose that high risk over 65 years old, particularly to drugs with risk factors.

Causing increased expertise nation in des <unk>.

<unk> or anti <unk> with improved profile.

Urgently needed.

Due to the limitations of the current antiviral options.

In addition to relax and safety concern the major issue of drug drug interaction between pack swabbing and commonly prescribed lifesaving drugs lead to a major unmet need among patients.

Risks with severe disease.

With many calls with you we have the potential to.

To address many of these limitations and it is our top priority to deliver this drug candidate as fast as possible.

Turning to slide five.

Just kind of two variants continuous display itself.

We are confident that <unk> will remain fully active.

Against ongoing and.

Future new variants based on the consistent.

In vitro antiviral activity that has been demonstrated against variance of concern indeed.

Our most recent data set.

Denver straight in vitro antiviral activity.

Or Mike.

Sub variants VA for MB at Phi.

Similar to the potency observed with Alpha beta Gamma Epsilon Delta and <unk>.

<unk> be a one NPA.

I will now turn the call over to John to review the only a few of our market opportunity for <unk> 19, John .

Good afternoon, everyone turning to slide six.

While initial COVID-19 revenues were driven by advanced government purchases. We believe the COVID-19 anti viral market will remain a very large market opportunity for years to come.

Pak <unk> Gabrielle are each multibillion dollar product, despite the limitations, which cause prescribing hesitancy.

Turning to slide seven.

Over the next year the U S Department of Health and Human services has suggested and we anticipate the U S market will transition from advanced government purchases to more traditional channels.

Which we expect will continue to be a multibillion dollar opportunity.

Projected annual current oral anti viral demand using acuity retail prescriptions suggest an estimated annual market between 10 and $20 billion.

And that we believe there is an opportunity to expand this market.

By simplifying prescribing for patients where <unk> drug drug interaction is of concern. There are several important classes, a commonly prescribed drugs that limit the ability to safely prescribed tax program.

Including seizure medications anti psychotics anti coagulant two more.

Additionally, the government is expected to move beyond advanced purchases.

Two recurring stockpile purchases once oral anti virals against COVID-19 are fully approved I'll now hand, the call over to China cabinet.

Good afternoon, turning to slide eight.

COVID-19 strategy is focused on the current highest unmet medical need.

Getting the most vulnerable patient populations, who are at the greatest risk for disease progression to severe COVID-19, and we'll kind of thing.

Theyre all the fewest treatment options available currently.

And the first advance results to date.

Jacob today's favorable personnel, including clinical benefits.

Safety and Tolerability and the low risk for drug drug interactions.

This profile should allow bend the cost of fast become the cornerstone of mono and combination oral therapy for the treatment of COVID-19.

Our combination antiviral chemical in the Sunrise trial will inform our future development strategy.

And we are at the forefront of developing combination therapy for specific populations such as the immuno compromised.

Then the Fosterville has already demonstrated additive benefit in vitro in combination with authorized direct acting antivirals, including <unk> inhibitors, and we continue to advance internal protease inhibitor program.

For combination therapy with <unk> plus.

Turning to slide nine.

The statistics shown unequivocally that hospital rates and death.

COVID-19 remained highest in the population, which we plan to study and these are the primary endpoint for the Sunrise trial.

In the U S. Alarmingly terrific 19 is now the third leading cause of death after heart disease and cancer with hundreds still dying daily.

According to the CDC approximately 75% of COVID-19 deaths, serving patients 65 years of age or older.

The CDC has also sanchez that 50% of hospitalized patients. There's a 65 have had at least three shot vaccine with rates of hospitalization a further three times higher.

Vaccination with adults.

It's important to note that in.

Immuno compromised patients greater hospitalization in excess of 20% have continued to be reported with omnicom.

Moving to slide 10.

Let's now review COVID-19 study design for Sunrise tree.

Phase III Registrational trial that will assess and necessity as both mono and combination antiviral therapy.

This global Phase III trial is a randomized double blind to see.

<unk> controlled study, which will evaluate them to foster their or placebo administered along with the local standard of care.

We expect to enroll at least 1500 high risk patients with mild or moderate COVID-19.

Patients will be randomized one to one to receive either <unk> 550 milligrams or placebo twice daily for five days.

Two study cohorts defined by the type of standard of care patients receive will be studied.

The first cohort is a monotherapy cohort, which will be comprised of patients receiving supportive care.

This represents the primary analysis population.

The second cohort is a combination antiviral cohort that will be comprised of patients who are receiving a compatible antiviral against COVID-19, as part of that literally available standard of care.

The primary endpoint of the study is all cause hospitalization or death through day 29.

30, <unk> hundred patients from the monotherapy cohort.

You will recall, we have already evaluated hospitalization in the morning Sky trial.

And then the faster faster to 71% reduction in hospitalizations.

Steven.

Importantly in addition, the subgroup analysis showed an 82% reduction in patients over the age of 40.

Moving to slide 11.

Sunrise three will focus on high risk patients.

Great risk for disease progression to severe COVID-19 or mortality.

This includes patients Acs odor.

<unk> 65 or older with one or more major risk factors for severe COVID-19.

<unk> compromised patients.

<unk>.

All of regardless of vaccination stations.

The study is expected to have a large global footprint with up to 300 sites in 25 countries.

It will include the United States Europe , Japan, and also the rest of the world.

We will imminently begin enrollment of the Sunrise trial in the United States and we have submitted or are in.

In the purchase of submission clinical trial applications in other countries.

Turning to slide 12.

Let's now review thank you perfect.

Thank you is the most prevalent mosquito borne virus disease globally and effect almost 400 million individuals on a yearly basis.

Thank is endemic in over 100 countries.

And more than half of the world's population is at risk.

Despite all of this.

No currently approved treatment options for dengue.

The phase two is a randomized phase two proof of concept study in patients with dengue fever that is enrolling in dengue endemic areas.

It is designed to assist antiviral efficacy safety and pharmacokinetics of multiple doses of 80 752.

With a primary endpoint of change in dengue virus viral load from baseline.

80, 752, or placebo are administered irony for five days and up to 60 patients in three cohorts maybe study.

Second. Thank you study is a human challenge muscle that is being conducted in the United States.

In this study healthy volunteers dosed with <unk>.

<unk> hundred <unk>, two or placebo and then administered alive Joseph dengue virus.

Subject to close to monitor in a very controlled setting, allowing assessment of viral load and the viral kinetics between the treatment groups.

We expect to complete enrollment in the challenge study and enrolment of the first cohort of 20 patients in the defense to study around the year end with results to follow.

Additionally, I would like to mention that we presented results from the <unk> seven phase two phase one study in 65 healthy volunteers last week at the American Society of tropical Medicine, and hygiene 2022 annual meeting.

These data demonstrated that <unk>, two was generally safe and well tolerated without drug related serious adverse events or discontinuation Doug.

<unk> levels above the in vitro <unk> hundred 90 <unk> achieved.

Based on these data we anticipate that <unk> two has the potential to rapidly inhibit thank you virus replication.

<unk> all here attached one through five.

Turning now to our hepatitis B program.

As shown on slide 10.

HCV combination program looks very promising and has potential to improve on the current standard of care.

HCV combination profile includes the potential for convenient and short duration Chris.

<unk> inhibitors pre treatment and the possibility for the first rather than frequency.

Compensated disease.

We believe <unk> in combination with spend the cost per year.

The opportunity to create a best in class.

Genotypic HCV therapy.

Chemical cloud applications will be submitted around the end of the year with the initiation of the phase two clinical trial to follow.

With that overview I'll now hand, the call over to Andreas to review our financial information.

Thank you Janet.

As Johnny mentioned in her introductory remarks earlier today, we issued a press release containing our financial results for the third quarter of 2022.

The statement of operations and balance sheet on slide 17 and 18.

R&D expenses decreased by $38 1 million from $43 <unk> million for the three months ended September 32021 to $4 9 million for the three months ended September 32022. The decrease in R&D expenses was primarily due to the elimination of the cost share arrangement with Roche or.

COVID-19 program collaborator and includes the credit in the amount of $14 5 million.

Related to the closed out by Roche of certain clinical trial activities that were previously the subject of the cost sharing arrangement.

General and administrative expenses remained relatively consistent at approximately $11 9 million for the three months ended September 32021, and $11 4 million for the three months ended September 32022.

Also in Q3, we recorded interest in other earnings on our cash reserves and the approximate amount of $4 4 million and we expect to receive a tax refund of approximately $3 7 million associated with the 2021 tax returns.

In closing with $665 million in cash cash equivalents and marketable securities at quarter end.

We're pleased to reiterate our cash guidance with a runway through 2000 Twenty's Taj.

I'll now turn the call back over to Sean <unk> for closing remarks.

Thank you Andrea.

We have made substantial progress advancing all three clinical candidates, which will take us through a pivotal year in 2023.

Our team is operating with a sense of urgency because there is an immediate need for new treatment options for COVID-19.

We will immediately.

Beginning enrollment of our global Sunrise III trial with the goal to deliver safe and effective.

All direct acting antivirals to patients as quickly as possible.

In addition, we.

We soon expect enrollment completion of the challenge study and the <unk>.

First quarter of different two for dengue with results to follow and the initiation of our phase two combination program, we made CB.

I would like to take the opportunity to thank the entire team.

His dedication to our mission.

Following the treatment severe viral diseases, and we said to them none of this progress would be possible.

With that operator, we will now.

On the call up to your questions.

Thank you at this time, we will conduct a question and answer session. As a reminder to ask a question you will need to press the star one one on your telephone keypad and wait for your name to be announced please standby, while we compile all Q&A roster.

Our first question comes from the line of MS. Hannah.

Good day.

De <unk> with JP Morgan Hana.

Hi, This is Hannah on for Eric Thanks for taking the questions. Just a brief remark for first can you speak to just the rationale behind doing the human Challenge study.

What questions do you think it's going to address separate from that of the inpatient dumping study and how informative do things that human trial and each day that might be.

Seeing the clinical activity of 85 752.

And then also can you characterize the datasets that we might be seeing from both phase III studies should we anticipate data from exploratory endpoints as well and when might we expect update children's perfect perfect. One cohorts. Thank you.

Jaret here.

Thanks for taking the questions.

Thank you, yes, so in regard to the rationale for the <unk> study and we think it's very complementary to the treatment study and should provide us with a really good idea of how 87 type II performs in dengue.

As mentioned the patient volume tests in the challenge study.

Minister the lives.

I'll touch on the background of either treatment with seven times to <unk> and so I think we really have.

A good example of the Nashville, Biokinetics Randy of infection in the placebo patients the potential for protection against infection altogether, but also I think a quick glimpse of whether the <unk> is.

The cases against infection, and so I think together, we get a good sense of what happens in the dengue infection and also what is likely to happen. If the drug is administered prophylactic too. So I think all together with two studies two.

Further should.

Give us a very good understanding of.

Hum seven two and performance against the <unk> and allow us to make the decisions around whether we need to have the cohorts and what type of dosing. We are looking at further in time.

Treatment durations and circle. So so I think I think they're going to be very informative. It is unfortunately, a disease, which is not all that well understood and so I think having some real world evidence in this way against this very important class.

And with regards to when we'll have data available as I mentioned, we plan to.

Complete first.

<unk> study as well as the initial cohort of patients in the phase II trial by year end and then we will analyze and to incorporate this data and that will allow us to make decisions around for questions. If any we need to answer.

The enrollment of subsequent cohorts if needed.

Okay. So you weren't getting data this year from any of those programs.

Well, we never committed to.

Data.

Okay.

It's going to be early next year.

We have indicated many times so in the same time, but I wanted to reiterate what Jeff was saying is that.

We are going to be the pioneer for.

For the treatment of <unk>.

Dengue.

As you know there is not a single direct acting antiviral that has been successful everyone knows failed.

So we are the pioneer both in turmoil.

Treatment duration.

The.

Long do it do we need.

Right now for five days, we have two weeks for the prophylactic.

We are learning from the.

The expert in the field that.

The rebound from the disease itself. So it's.

Janet as indicated we are waiting to have both studies to make sense of both studies are highly complementary as proof of concept and then the stand.

We are going to move forward into larger studies.

Okay, great. Thanks for taking the question.

Thank you. Our next question comes from the line of Matthew Harrison.

Morgan Stanley Matthew Please standby.

Sanjay.

What level of viral load reduction of four Sanjay if they make hold you can be nimble are all.

Perhaps more important thank you.

Jaret.

So it's an interesting question Matthew.

Fitness, Julie I think we're going to learn a lot as I said from having firstly.

The patients on the placebo group as well as on the.

Active in the in the prophylactic study and and also in the treatment study I think to be able to compare and contrast, we know that the volume the decline very rapidly naturally after a couple of days.

But once we're interested to see whether we can get it to come down more quickly.

Some of what you're asking I think we don't really know the answer is no longer effective therapies.

It's possible ready to make that assessment yet.

Okay. Thank you.

Okay. Our next question comes from the line of Omar Robot will ever core.

Omar please standby.

Palmer Your line is open.

Thank you.

A couple of questions. If I may 1st we saw Gilead post the phase III trial of their oral Ram death, severe pill and Theres a couple of things that stand out versus your trial design first gilead using almost two X the powering.

And second they are limiting the trial for patients with at least four months or more since the last vaccine dose.

Maybe if you could speak to those dynamics in those two dimensions as you thought about your trial design number one and secondly back on dengue, perhaps just to pick up on the prior question.

If the viral load truly is declining so rapidly after a couple of days.

Is that consistent in patients that do end up getting hospitalized because I got I imagine some sort of hospitalization endpoint is what leads to ultimate utilization and perhaps even approval and.

And if you could also speak to the human Challenge study that you are attempting to Ron that was only 12 patients I didn't hear you say much on that where do we stand on that thank you.

Got it.

Thank you Hey, with regards to Gilead phase III trial.

I haven't seen the study design, so I can't comment on how the population compares to us and with regard to the powering.

I am really unable to comment.

With regard to the more than four months requirements since the last vaccination again I don't know.

Without doing the study, but I can say that for US study, we have a truly global footprint as I mentioned and more than 25 countries.

I think you'll be very aware of the fact that not everybody is getting the same vaccines and not everybody gets.

Getting them on the same schedule, so we think that.

In order to allow the study to enroll the most pragmatic way is ready to allow patients to come in regardless of vaccination space. If they get COVID-19, because that's really what they care about.

And we'll see what the hospitalization rates. Unlike unfortunately, I think in the patient population that we're planning to study in this study the immune responses to the vaccine can be quite limited anyway. So we think that many of these patients are unfortunately is still going to be fairly susceptible to COVID-19, and you'll recall I mentioned on.

The core around the data.

50% of patients.

And 65 being hospitalized having had leased three Chuck divesting in the U S and Jackie.

I think I think west of <unk>, Unfortunately to see a fairly good representation of patients being hospitalized with England huffing back small sats.

And again.

It's a pragmatic approach in order to be able to help us to take the study forward and we'll have to see how that translates.

With regard to <unk>.

And and the rapidity of the decline.

No that's the BARDA does decline rapidly.

And I think to some extent, we don't yet know how that translates into the need for hospitalization work. We do here is back.

Patients are repeatedly infected with dengue.

<unk> causes the hospitalization.

Ian function, leading to cash kind of storm.

<unk>.

Sorry to transform relates to rapidity of decline environment. I think is uncertain I think the main thing is that it's important to eradicate the virus as quickly as possible to help reduce the tranches for that part of the immune response, but again.

This is a this is really the front end of a learning curve for everybody with therapeutics forecast for dengue.

Sure.

Hello, I'm, sorry, just just to add and then I'll, let you.

So the challenge is.

John that's above the viral load promo Ben the only correlation to be made.

That.

We will appear to suggest that viral load.

Cotton for severity of the disease is that the.

The two strain.

The strength.

Q1, and then get to the one.

One was the highest.

Viral load then they'll go on that.

Basically closing the majority of serious disease, so that that's where there was some kind of.

Correlation, but but nothing more.

More than that.

Janet address the challenge part also.

John .

So with regards to the challenge study were listed in the purchase of enrolling the cohort.

The 12 patients into that cohort.

There isn't much more that I can provide in the way of an update.

And take that.

Wrapping up fairly shortly now.

Thank you our next call will come from the line of Tim Lugo with William Blair, Tim Please standby, while I open your line up.

Taking the question.

Yes, Jeremy Yes, Youre line is open okay great.

Combination patients that youre going to be getting out of Sunrise three.

Is it safe to assume that those are going to be mostly elderly or immune compromised or is that more just the geographics.

I guess division.

Division between who would receive combination therapy, who want it.

Janet.

Sure.

I think it's really it's going to depend on the prescribed that to some extent some of it will be geographic in terms of access to.

Brita Antivirals are available.

And standards of care.

Yes.

For many patients.

Particularly in the United States, it's likely that patients.

Will be limited to monotherapy, if they're all significant drug interactions preventing them from getting past COVID-19, but they are still also able to be prescribed monitor available there that doesn't seem to be much that is prescribed.

I think I think it's likely and we anticipate that there will be more combination use.

Where do you across the board.

In certain areas of the world, but I think again, the unmet need seems to be.

Even in those areas.

The personnel of the drugs that are currently available rather close to some reluctance in prescribing awesome.

Okay, and do you have a sense of rebound I know, that's obviously very topical.

The popular press a lot, but so.

So we really have any good data on rebound right.

For for oral therapy.

Hello.

Sure.

Yes.

I think I think youll, probably reading the same Richards have the time and quite honestly I think its perplexing still.

The rates seem to be variable one has also.

Patients not receiving therapy, who also experienced relapse.

I think I think it's difficult to be certain.

The anecdotal experience that <unk> has.

Experiencing relapsed rebound and what is written in the literature also seem to be somewhat divergence.

No I don't have a good idea yet.

Understood. Thank you.

Yeah.

Our next question will come from the line of Nick <unk> with S. DB Securities. Nick Please standby, while I open up your line.

Hi, good guesses on for Rwanda release should be securities. Thanks for taking your questions first off for the new Phase III COVID-19 program. I was just curious are you planning to feature both primary and secondary endpoint data in the interim analysis.

So when do you expect to share these results.

Jonathan.

So we're anticipating that we'll have results from the interim analysis.

In the second half of next year.

And I don't think we've discussed whether we're going to showcase based on both primary and secondary.

And so I can't answer that today.

Got it thanks, Janet and then one follow up on the COVID-19 program.

MS Stratify results based on our.

Individual patient throughout the us.

Got it.

I'm sorry based on individual.

Patients.

You've got us.

No. We're not we're not we're not going to satisfy a big based on anything and I think the terrorists jurisdictions will taken us awhile to get there.

We will not be doing that.

Got it that's very helpful. And then a couple of questions on <unk>. If you don't mind are there any adverse events or safety signals youre watching for in particular.

Some of the higher doses of 75, two related Gi related for the two ongoing clinical trials.

Sure.

So the basically selected four.

For our clinical trial with <unk> two.

Is safe and well tolerated and no. We don't think that that would be STI technologically there's degrees collected.

That's very helpful and lastly.

How might the broader availability of Takeda is our new dengue vaccine I guess impact.

The landscape for new Therapeutics in this space and maybe what implications could this have for for the development of 75 to in the future.

Jonathan you want to address with John .

So I can start and then and then touch on you might like to take over there.

Sure.

I think that the.

<unk>.

Unfortunately, following on the heels of a vaccine, which led to some severe adverse reactions and so I think there was.

The concerns Houston initially that's about vaccine uptake. So I think that may be a problem. Unfortunately for people.

And.

I think the population at large intended for.

Starting off with with children rally, which makes a lot of sense, but I think leaves leaves a large unmet need for many people who live in dengue endemic areas uncertainty I think.

Secondly, the question is around the.

Your ability of the vaccine and people concerned with in dengue endemic areas potentially visiting dengue endemic areas and meeting something shorter term Paul.

Treatment or prevention. So I think I think I think you were.

One or two to the vaccine may actually drive people being more aware of the need for therapy, Tom I'll hand, it over to you.

Yes, so I think a lot with Ted so obviously in the endemic areas.

We welcome the fact that they could have a vaccine because theres been nothing there, but there is durability of specifically looking at Takeda vaccine. After three years. It is starting to come down given the past experience in those areas with no feedback theme.

We're disappointed by many of those countries.

It's going to be interesting to see what the uptake is there.

But for Gregg wealthier countries, where it might be more of a travelers who market.

Particularly if you look at the travelers market in the United States.

It's one of the travelers are reluctant to get a vaccine, particularly a series before they travel we thought with hepatitis day, we saw it with others. So an oral prophylactic prophylactic.

Four four for prophylaxis of travel is really would be the preferred there.

Then of course, even with the with the military and so forth, where maybe youre not going to be other Josh as scheduled.

Yes.

Can you hear me.

Okay.

Yes.

Can you hear me.

Yes go ahead.

Yes, yes, so I was just saying that and.

Particularly for the travels related market, an oral prophylactic would be preferred than getting a.

Vaccination for dengue fever.

Got it very helpful. Thanks al.

If you would like to pose a question. Please feel free to dial star one on your telephone keypad.

If there are no further questions I would like to turn the call back over to Mr. J P.

Pharma dose.

For his closing comments J P.

Thank you again for joining us today. Thank you.

Thank you for your participation in today's conference call. This concludes the call you may now disconnect.

The conference will begin shortly.

To raise your hand during Q&A you can dial star one one.

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Good afternoon, ladies and gentlemen, welcome to the <unk> Pharmaceuticals third quarter 2022 financial results and business update conference call at this time all participants.

<unk> and <unk>.

Listen only mode.

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

In order to ask a question. Please dial one one on your telephone keypad I will now turn the call over to G&A bonds Senior Vice President of Investor Relations and corporate communications at <unk> Pharmaceuticals Ms. Barnes. Please proceed.

Thank you operator, good afternoon, everyone and welcome to <unk> Pharmaceuticals third quarter 2022 financial results and business update conference call earlier today, we issued a press release, which outlines the topics. We plan to discuss you can access the press release as well as the slides that we'll be reviewing today by going to the <unk>.

<unk> section of our website at IR Taiyo pharma Dot Com with me today from our Chief Executive Officer, and founder Dr. John <unk>.

Development Officer, Dr. Janet Hammond.

Financial Officer, and executive Vice President of legal Andrea Corcoran, and our Chief commercial officer, John Breaker. 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 risks and uncertain.

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.

Thank you John .

Good afternoon, everyone and thank you for joining us we have a number of updates to review with you today.

Demonstrate the considerable progress we have made so far this year across our Sui clinical program.

Turning to slide four.

We assess COVID-19 landscape.

The rapid increase in dominance of multiple new variants in different regions of the world combined with social dynamics back to near pre pandemic norms.

Neologize predicts that COVID-19 will persist with multiple wave as we currently see today.

They're wanting to do a bill or the associated with vaccines and.

In natural and factual.

And the low uptake in the number of people receiving their old crop booster vaccine with only less than 10% in the U S. Currently.

We continue to close large numbers of <unk>.

Practice individuals and reinforce the need for a new direct acting antiviral.

Looking forward as we.

Start enrollment of Sunrise.

Our global Phase III Registrational trial.

Ongoing waves with VA is not susceptible to currently available preventive tools shouldn't enable timely.

Timely enrollment of patients for this trial.

Pandemic, probably 19 ways can be life threatening.

Is that the high risk over 65 years old, particularly to drive us with risk factors.

Causing increased expertise nation in des <unk>.

<unk> or <unk> with improved profile.

Urgent plea needed.

Due to the limitations of the Cowen. Thank you all options.

In addition to relapse and safety concern the major issue of drug drug interaction between pack swabbing and commonly prescribed lifesaving drugs lead to a major unmet need among patients.

Cereal disease.

Was there any cost review, we have the potential to.

The address many of these limitations and it is our top priority to deliver this drug candidate as fast as possible.

Turning to slide five.

<unk> got two variants continuous this plateau.

We are confident that Benny Crosby, and we remain fully active.

Against ongoing.

Future new variants based on the consistent.

In vitro antiviral activity that has been demonstrated against variance are concerned indeed.

Our most recent data Scott.

Demonstrate in vitro antiviral activity against or Mike Raab sub variants VA for MB at Phi.

Similar to the potency observed with alpha beta and gamma.

Absolutely Doug.

And I'll make.

Sure.

One NBA too.

I will now turn the call over to John should we view on a few of our market opportunity for probably 19 John .

Good afternoon, everyone turning to slide six.

While initial COVID-19 revenues were driven by advanced government purchases. We believe the COVID-19 anti viral market will remain a very large market opportunity for years to come.

Pac level Vivek Gabrielle are each multibillion dollar product, despite the limitations, which cause prescribing hesitancy.

Turning to slide seven.

Over the next year.

Department of Health and Human services has suggested and we anticipate the U S market will transition from advanced government purchases to more traditional channels.

Which we expect will continue to be a multibillion dollar opportunity.

Projected annual Covid oral antiviral demand using Ikea the retail prescriptions suggest an estimated annual market between 10 and $20 billion.

And that we believe there is an opportunity to expand this market.

By simplifying prescribing for patients where <unk> drug drug interaction is of concern. There are several important classes of commonly prescribed drugs that limit the ability to safely prescribed tax policy.

Including seizure medications anti psychotics anti coagulant two more.

Additionally, the government is expected to move beyond advanced purchases.

<unk> recurring stockpile purchases once oral anti virals against COVID-19 are fully approved I will now hand, the call over to Chad Kevin.

Good afternoon, turning to slide eight.

COVID-19 strategy is focused on the current highest unmet medical need with.

We're targeting the most vulnerable patient populations, who are at the greatest risk for disease progression to severe COVID-19 will Tennessee and for whom there are fewer treatment options available currently.

<unk> results to date demonstrate its very favorable profile, including clinical benefits at safety and Tolerability and the low risk for drug drug interactions.

This profile should allow them to pass the vast become a cornerstone of mono and combination oral therapy for the treatment of COVID-19.

Our combination antiviral chemical in the Sunrise III trial will inform our future development strategy.

And we are at the forefront of developing combination therapy for specific populations such as the immuno compromised.

For combination therapy with <unk> plus.

Moving to slide nine.

The statistics sure unequivocally that hospital rates and death.

COVID-19 remained highest in the population, which we plan to study and these are the primary endpoint for the Sunrise trial.

In the U S. Alarmingly terrific 19 is now the third leading cause of death after heart disease and cancer with hundreds still dying daily.

According to the CDC approximately 75% of COVID-19 deaths, serving patients 65 years of age or older.

The CDC has also stated that 50% of hospitalized patients further 65 have had at least three shot vaccine with rates of hospitalization a further three times higher.

Vaccination with adults.

It's important to note that in.

Immunocompromised patients hospitalized.

Hospitalization in excess of 20% have continued to be reported with omnicom.

Moving to slide 10.

Let's now review.

19 study designed to Sunrise III phase.

Phase III Registrational trial second assess then the faster that as both mono and combination antiviral therapy.

This global Phase III trial is a randomized double blind placebo controlled study, which will evaluate them to foster that all placebo administered along with the local standard of care.

We expect to enroll at least 1500 high risk patients with mild or moderate COVID-19.

Patients will be randomized one to one to receive either <unk> 550 milligrams or placebo twice daily for five days.

Two study cohorts defined by the type of standard of care patients receive will be studies.

The first cohort is a monotherapy cohort, which will be comprised of patients receiving supportive care and this represents the primary analysis population.

Second cohort is a combination antiviral cohort and will be comprised of patients who are receiving a compatible antiviral against COVID-19, as part of that literally available standard of care.

The primary endpoint of the study is all cause hospitalization or death through day 29.

30, <unk> hundred patients from the monotherapy cohort.

You will recall, we have already evaluated hospitalization in the morning Sky trial, and then of course, the vast showed a 71% reduction in hospitalization.

<unk>.

Importantly in addition, the subgroup analysis showed an 82% reduction in patients over the age of 40.

Moving to slide 11.

Three we will focus on high risk patients.

As far as the greatest risk for disease progression to severe COVID-19 or mortality.

This includes patients with Acs older patients.

Patients 65 or older with one or more major risk factors for severe COVID-19.

Immuno compromised patients.

<unk>, all regardless of vaccination.

The study is expected to have a large global footprint with up to 300 sites in 25 countries, which will include the United States Europe , Japan.

And also the rest of the world.

We will imminently begin enrollment of the Sunrise trial in the United States and we have submitted or are.

And the purchase of submission clinical trial applications in other countries.

Turning to slide 12.

Let's now review Thank you program.

Thank you is the most prevalent mosquito borne virus disease globally and effect almost 400 million individuals on a yearly basis.

Thank you is endemic in over 100 countries.

And more than half of the world's population is at risk.

Despite all of this there are no currently approved treatment options for dengue.

The phase two is a randomized phase two proof of concept study in patients with dengue fever that is enrolling in dengue endemic areas.

It is designed to assist antiviral efficacy safety and pharmacokinetics of multiple doses of <unk> hundred 70 <unk> two.

With a primary endpoint of change in dengue virus viral load from baseline.

80, 752, or placebo are administered irony for five days and up to 60 patients in three cohorts may be studied.

Second. Thank you study is a human challenge model that is being conducted in the United States.

In this study healthy volunteers dosed with <unk> hundred <unk>, two or placebo and then administered <unk> Joseph dengue virus.

Subject to Christian Monotype is in a very controlled setting, allowing assessment of viral load and the viral kinetics between the treatment groups.

We expect to complete enrollment in the challenge study and enrolment of the first cohort of 20 patients in the <unk> two study around the year end, which results to follow.

Additionally, I would like to mention that we presented results from the 87 phase two phase one study in 65 healthy volunteers last week at the American Society of tropical Medicine, and hygiene 2022 annual meeting.

These data demonstrated that <unk> was generally safe and well tolerated without drug related serious adverse events or discontinuation.

Doug Chasma levels above the in vitro <unk> hundred 90 <unk> achieved.

Based on these data we anticipate that <unk> two has the potential to rapidly inhibit thank you virus replication.

Thus all serotypes one through five.

Turning now to our hepatitis B program.

As shown on slide 13.

HCV combination program looks very promising and has potential to improve on the current standard of care.

HCV combination profile includes the potential for convenient and short duration Chris.

<unk> inhibitor three treatment and the possibility for the first rather than frequency decompensation.

Key compensated disease.

We believe <unk> in combination with bend the cost per day.

The opportunity to create a best in class.

Genotypic HCV therapy.

Clinical cloud applications will be submitted around the end of the year with the initiation of the phase two clinical trial to follow.

With that overview I'll now hand, the call over to Andreas to review our financial information.

Thank you Janet.

Tony mentioned in her introductory remarks earlier today, we issued a press release containing our financial results for the third quarter of 2022.

The statement of operations and balance sheet on slide 17 and 18.

R&D expenses decreased by $38 1 million from $43 million for the three months ended September 32021 to $4 9 million for the three months ended September 32022. The decrease in R&D expenses was primarily due to the elimination of the cost share arrangement with Roche or.

Former COVID-19 program collaborator and includes the credit in the amount of $14 5 million.

Related to the closed out by Roche of certain clinical trial activities.

Obviously, the subject of the cost sharing arrangements.

Also in Q3, we recorded interest in other earnings on our cash reserves to meet you.

Approximate amount of $4 4 million and we expect to receive a tax refund of approximately $3 7 million associated with the 2021 tax returns.

In closing with $665 million in cash cash equivalents and marketable securities at quarter end.

We are pleased to reiterate our cash guidance with a runway through 2000 Twenty's Taj.

I'll now turn the call back over to Sean <unk> for closing remarks.

Thank you Andrea.

Substantial progress advancing all three clinical candidates, which will take us through a pivotal year in 2020 is correct.

Our team is operating with a sense of urgency because there is an immediate need for new treatment options for COVID-19.

We will immediately.

Beginning enrollment of our global Sunrise III trial with the goal to deliver safe and effective.

All direct acting antiviral to patients as quickly as possible.

In addition.

We soon expect enrollment completion of the challenge study and the first quarter of different two for dengue with results to follow and the initiation of our phase two combination program, we made CBD.

I would like to take the opportunity to thank the <unk> team for their.

His dedication to our mission.

Following the treatment severe viral diseases, and we said to them none of this progress would be possible.

With that operator, we will now.

On the call up to your questions.

Thank you at this time, we will conduct a question and answer session. As a reminder to ask a question you will need to press the star one one on your telephone keypad and wait for your name to be Enel. Please standby, while we compile all Q&A roster.

Our first question comes from the line of MS. Hannah.

Odd date, OA with J P Morgan Hana.

Hi, This is Hannah on for Eric Thanks for taking the questions. Just a brief remarks for first can you speak to just the rationale behind doing the human Challenge study.

Do you think it is going to address separate from that of inpatient dumping study.

And how informative these things start human trial these data might be empty youre seeing the clinical activity of 85 752.

So can you characterize the datasets that we might be seeing from both phase III studies should we anticipate data from exploratory endpoints as well.

And when might we expect update children's perfect perfect weight cohorts. Thank you.

Jaret here.

Taking the questions.

Thank you, yes, so in regard to the rationale for the <unk> study.

Thank very complementary to the treatment study.

And should provide us with a really good idea of how <unk> performs in dengue.

As mentioned the patient volume tests in the challenge study are administered a knife.

That's on the background of either treatment with seven times to <unk> and so I think we really have.

A good example of the Nashville Biokinetics Randy.

Section in the placebo patients the potential for protection against infection altogether.

I think a quick glimpse of whether the <unk> is efficacious against infection and so I think together, we get a good sense of what happens in the dengue in question and also what is likely to happen. If the drug is administered prophylactic too. So I think all together the two studies together should give us a very good understanding.

Of.

Hum seven type two and performance against the <unk> and allow us to make the decisions around whether we need for the cohort and what type of dosing we are looking at further.

In terms of treatment durations and circle.

I think they're going to be very informative. It is unfortunately, a disease, which is not all that well understood and so I think having some real well.

Evidenced in this way against the very important point.

And with regard to when we'll have data that's available as I mentioned, we plan to.

Complete first the challenge study as well as the initial cohort of patients in the phase II trial by year end and then we will analyze and to incorporate this data and that will allow us to make decisions around for questions. If any we need to answer.

As you can.

The enrollment of subsequent cohorts if any.

Okay. So you won't getting data this year from any of those programs.

Well, we've never committed to.

Data.

Okay.

It's going to be early next year.

You have indicated many times.

At the same time.

I'd like to reiterate towards China was saying is that.

We are going to be the pioneer.

For the treatment of <unk>.

Dengue so far as you know there was talk with single direct acting antiviral that has been successful everyone has failed.

So we are the pioneer both in term of treatment.

Treatment duration.

The.

Long do it do we need.

Right now for five days, we had two weeks ago the prophylactic.

We are learning from.

The expert in the field that there may be some rebound from the disease itself. So it's.

Janet.

Indicated we are waiting to have both studies.

Makes sense of both studies are highly complementary.

If a concept and then the stand.

We are going to move forward into larger studies.

Okay, great. Thanks for taking my questions.

Thank you. Our next question comes from the line of Matthew Harrison.

Morgan Stanley Matthew Please standby.

Sanjay so what level of viral load reduction.

Let me make hold you can be nimble our Ala Carte map has more important thank you.

Jaret.

So it's an interesting question Matthew.

<unk> necessarily I think we're going to learn a lot.

Aside from having both the the.

Patients on the placebo group as well as on the.

<unk> active in the in the prophylactic study and and also in the <unk>.

<unk> study I think to be able to compare and contrast, we know that the buyer and the decline very rapidly naturally after a couple of days.

What we're interested to see whether we can get it to come down more quickly, but some some of what you're asking I think we don't really know the answer is no longer effective therapies I don't think its possible ready to make that assessment yet.

Okay. Thank you.

Okay. Our next question comes from the line of Omar Robot will ever core Omer. Please standby.

Palmer Your line is open.

Thank you.

A couple of questions. If I may 1st we saw Gilead post the phase III trial of their oil Gram deciliter pill and Theres a couple of things that stand out versus your trial design first delegate using almost two X the powering.

Second they are limiting the trial for patients with at least four months or more since the last vaccine dose.

Maybe if you could speak to those dynamics in those two dimensions as you thought about your trial design number one and secondly back on dengue, perhaps just to pick up on the prior question.

If the viral load truly is declining so rapidly after a couple of days.

Is that consistent in patients that do end up getting hospitalized because I got to imagine some sort of hospitalization endpoint is what leads to ultimate utilization and perhaps even approval and.

And if you could also speak to the human Challenge study that you are attempting to Ron that was only 12 patients I didn't hear you say much on that where do we stand on that thank you.

Janet.

Thank you so with regards to Gilead phase III trial.

I haven't seen the study designs the icon.

On how the population compares to us and with regard to the powering.

Im really unable to comment.

With regard to me more than four months requirements since the last vaccination again either.

Good progress.

Without doing the study, but I can say that for US study, we have a truly global footprint as I mentioned and more than 25 countries.

I think you'll be very aware of the fact that not everybody is guessing the same vaccines and not everybody gets.

Getting them on the same schedule, so we think that.

In order to allow the study to enroll the most pragmatic way is ready to allow patients to come in regardless of vaccination space. If they get COVID-19, because that's really what they care about.

And we'll see what the hospitalization rates on that Unfortunately, I think in the patient population that we're planning to study in this study the immune response to the vaccine can be quite limited anyway. So we think that many of these patients are unfortunately is still going to be fairly susceptible to COVID-19, and you'll recall I mentioned on.

The core around the data.

50% of patients over the age of 65 being hospitalized having had at least three shop divesting in the U S.

So I think I think we're still lucky unfortunate to see a fairly good representation of patients being hospitalized with Eagle Ford <unk> backhaul.

And again.

It's a pragmatic approach in order to be able to help us to take the study forward and we'll have to see how that translates.

With regard to borrowers.

And and the rapidity of the decline.

We know that the BARDA does decline rapidly.

And I think to some extent, we don't yet know how that translates into the need for hospitalization work. We do here is back.

Patients are repeatedly infected with dengue.

Any causes the hospitalization.

Ian function, leading to cash kind of storm.

And.

How to transform relates to rapidity of.

The current environment I think is uncertain I think the main thing is that it's important to eradicate the virus as quick as possible to help reduce the transit Paul that passes immune response, but again.

This is a this is really the front end up a learning curve for everybody with therapeutics focused for dengue.

Sure.

Oh I'm, sorry, just just to add and then I'll, let you.

The challenge is to create.

Jana that's above the Waterloo promo Ben.

Any correlation to be made.

That.

Appear to suggest that viral load.

Portland for severity of the disease is that the.

The two strain.

The strength.

The one and then get to the <unk>.

One was the highest.

Viral load then they'll go on that.

Basically closing the majority of several disease. So so.

That's where there was some kind of.

Correlation, but but nothing.

More than that.

I'll, let Janet address the challenge Bank also.

Jonathan.

So with regards to the challenge study were listed in the purchase of enrolling the cohort of the code.

The 12 patients into that cohort so.

There isn't much more that I can provide in the way of an update Berkeley.

Anticipate.

Wrapping up fairly shortly now.

Thank you our next call will come from the line of Tim Lugo with William Blair, Tim Please standby, while I open your line up.

Taking my question.

Yes can you hear me, yes, Youre line is open broker great.

Sort of a combination patients that youre going to be getting out of sunrise three.

Is it safe to assume that those are going to be mostly elderly or immune compromised or is that more just the geographics.

I guess division.

Division between who will receive combination therapy, who waited.

Janet.

Sure.

I think it's really it's going to depend on the prescriber to some extent some of it will be geographic in terms of access to.

Potential barrels are available.

And standards of care in an area I think.

For many patients.

In the United States, it's likely that patients will.

We will be limited to monotherapy, if they're all significant drug interactions preventing them from getting pass COVID-19, but they also offer able to be prescribed monitor that although that doesn't seem to be much stuff as prescribed.

I think I think it's likely and we anticipate that there will be more combination use.

Randy across the board.

In certain areas of the world, but I think again, the unmet need seems to be.

Even in those areas that.

The profile of the drugs that are currently available rather causes some reluctance in prescribing awesome.

Okay do you have a sense of rebound I know thats, obviously very topical.

The popular press a lot, but so.

So we really have any good data on rebound right.

For oral therapy.

Hello.

Sure Jack.

Yes.

I think I think youll, probably reading the same research at the time and the and quite honestly I think it's protecting still.

The rates seem to be variable one has also.

Patients not receiving therapy, who also experienced relapse.

I think I think it's difficult to be certain.

The anecdotal experience that <unk> has.

Experiencing relapse, so rebound and what is written in literature also seem to be somewhat divergence.

No I don't have a good idea yet.

Understood. Thank you.

Okay.

Our next question will come from the line of Nick <unk> with ex BB Securities. Nick Please standby, while they open up your line.

So when do you expect to share these results.

Janet.

So what we're anticipating.

The pacing that we will have results from the interim analysis in the second half of next year.

And I don't think we've discussed whether we're going to showcase based on both primary and secondary.

And so I can't answer that today.

Got it thanks, Janet and then one follow up on the COVID-19 program are you planning to stratify results based on.

Individual patients throughout the us.

Got it.

And so based on what the.

Individual patients.

Zero status.

No we're not.

We're not we're not based on anything and I think the <unk> jurisdictions will taken us awhile to get there.

We will not be doing that.

Got it that's very helpful. And then a couple of questions on <unk>. If you don't mind are there any.

Bruce events or safety signals youre watching for in particular, some of the higher doses of 75 to maybe Gi related for the two ongoing clinical trials.

Sure.

So the dose that we selected for.

For our clinical trials with <unk> <unk> two.

Is.

And well tolerated and no. We don't think that that would be hai technologically there's degrees collected.

That's very helpful and lastly.

How might the I guess broader availability of Takeda is our new dengue vaccine I guess impact.

The landscape for new Therapeutics in this space and maybe what implications could this have for for the development of 75 to in the future.

Jonathan you want to address that John .

So I can start and then John you might like to take over there.

Sure.

I think back to the.

<unk>. Unfortunately, following on the heels of a vaccine, which led to some severe adverse reactions and so I think there is.

The concern shift initially that's about vaccine uptake. So I think that may be a problem. Unfortunately for people.

And.

I think the population at large intended for.

Starting off with with children rally, which makes a lot of sense, but I think leaves leaves a large.

MS Meek, who have many people who live in dengue endemic areas uncertainty I think secondly, the question is around the durability of the vaccine and people concerned with in dengue endemic areas potentially visiting dengue endemic areas and meeting something shorter term Paul.

Treatment or prevention. So I think I think I think the awareness to the vaccine may actually drive people being more aware of the need for therapy, Tony I'll hand, it over to you.

Yes, So I think a lot was said so obviously in the endemic areas.

We welcome the fact that they could have a vaccine because theres been nothing there, but theres durability, specifically looking at Takeda vaccine. After three years. It is starting to come down given your past experience in those areas with Sanofi vaccine.

And we are disappointed by many of those countries.

It's going to be interesting to see what the uptake is there.

But for great wealthier countries, where it might be more of a travelers market.

Particularly if you look at the travelers market in the United States.

It's one of the travelers are reluctant to get a vaccine, particularly a series before they travel we thought with hepatitis day, we saw with others. So an oral prophylactic prophylactic.

Four four for prophylaxis of travel is really would be the preferred there.

And then of course, even with the with the military and so forth, where maybe youre not going to be Josh This category.

Yes.

Can you hear me.

Yes.

Okay.

Yes can you hear me.

Yes go ahead.

Yes, yes, so I was just saying that.

Particularly for the travels related market, an oral prophylactic would be preferred and then getting a.

Vaccination for dengue fever.

Got it very helpful. Thanks al.

If you would like to pose a question. Please feel free to dial star one on your telephone keypad.

If there are no further questions I would like to turn the call back over to Mr. J P.

Soma dose.

For his closing comments J P.

Thank you again for joining us today. Thank you.

Thank you for your participation in today's conference call. This concludes the call you may now disconnect.

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