Q1 2022 Atea Pharmaceuticals Inc Earnings Call

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Unknown Executive: We appreciate your patience. Bye.

Good morning, and welcome to the attack Pharmaceuticals first quarter 2022 earnings conference call. Currently all colors have been placed in a listen only mode to prevent.

Operator: Bye, your program is about to begin. If you need assistance during your conference, please press star 1. Good morning and welcome to the Atea Pharmaceuticals First Quarter 2022 Earnings Conference Call. Currently, all callers have been placed in a listen-only mode to prevent, and following the management's prepared remarks, the call will be open to questions. If you would like to ask a question at any time, please press star 1 on your telephone keypad. If you need to remove yourself from the queue, please press star 2.

And following the management's prepared remarks, the call will be open for questions. If you would like to ask a question at any time. Please press star one on your telephone keypad.

If you need to remove yourself from the queue. Please press star two.

Operator: At any time, if you need operator assistance, please press star zero. Please be advised that today's call is being recorded. I will now turn the call over to Jonae Barnes, Senior Vice President of Investor Relations and Corporate Communications at Atea Pharmaceuticals. Thank you; you may begin.

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Operator assistance, Please press star zero.

Please be advised that today's call is being recorded I will now turn the call over to Jenny Barnes Senior Vice President of Investor Relations and corporate communications at Teva Pharmaceuticals. Thank you you may begin.

Jonae Barnes: Good morning, everyone, and welcome to Atea Pharmaceutical's first quarter 2022 financial results conference call. This morning, we issued a press release that outlines the topics we plan to discuss, including newly released data for Benifazivir for the treatment of COVID-19. You can access the press release, as well as the slides that we'll be reviewing today, by going to the investor section of our website at ir.ateafarma.com. With me today for Atea are Chief Executive Officer and Founder, Dr. John Pierre Somodosy, Chief Development Officer, Dr. Janet Hammond, Chief Financial Officer and Executive Vice President of Legal, Andrea Corcoran, and our Chief Commercial Officer, John Va

Good morning, everyone and welcome to Acadia Pharmaceuticals first quarter 2022 financial results Conference call. This morning, we issued a press release, which outlines the topics we plan to discuss including newly released data for many parts of Europe for the treatment of COVID-19, you can access the press release as well as the slides that we'll be reviewing today.

I like going to the investors section of our website at IR dot to pay your pharma Dot Com with me today from our Chief Executive Officer, and founder Dr. John Here's how much Oc Chief Development Officer, Dr. Janet Hamon, Chief Financial Officer, and Executive Vice President of legal and try your Corcoran and our chief commercial.

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Well 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 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.

Jonae Barnes: We will all be available for the Q&A portion of today's call. Before we begin the call, as outlined on slide two, I would like to remind you that today's discussion will contain forward-looking statements that involve risk and uncertainties. These risks and uncertainties are outlined in today's press release and in the company's recent filings with the Securities and Exchange Commission, which we encourage you to read. Our actual results may differ materially from what is discussed on today's call. With that, I'll now turn the call over to John Pierre. Thank you, Jonae.

Our actual results may differ materially from what is discussed on today's call with that I'll now turn the call over to John here.

John Pierre Somodosy: Good morning, everyone. And thank you for joining us today. We have a lot of new information to review this morning, and this includes exciting new data for Benifazbevir showing, for the first time, clinical benefits in a meaningful number of patients in the Phase III MorningSky trial and also in the Phase II Hospitalized Study. These new results are very important for the future direction of the program and definitely indicate clinical benefit for COVID-19 patients treated with benifozbivir.

Thank you John Good morning, everyone and thank you for joining us today.

We have a lot of information to review this morning.

This includes exciting new data for any false Vivian showing for the first time clinical benefits and the meaningful number of patients in the phase III bombing Sky trial, and also interface to us with a lifestyle.

This new start these new results are very important for the future direction of the program.

Definitely indicate clinical benefit.

COVID-19 patients treated with Fannie Fosterville.

John Pierre Somodosy: The results, as I said..., show a meaningful reduction in hospitalization in a very broad patient population treated in the outpatient setting and also clinical benefits in high-risk, hospitalized COVID-19 patients, and Janet will go over the details with you in a few minutes. In addition, new in vitro data demonstrate the broad antiviral activity of benifozbivir across variants of concern, including the Omicron variant.

The results as I said.

So a meaningful reduction in hospitalization in a very broad patient population.

Treated in the outpatient setting and also clinical benefits in a high risk hospitalized COVID-19 patients and John will go over the details with you in a few minutes in addition.

In vitro data demonstrate the broad antiviral activity of any false view Clos variance of concern.

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John Pierre Somodosy: These results leave us particularly encouraged that we are well positioned to meet the challenges of this global pandemic and support the next chapter of our clinical development program. Beyond COVID-19, we have made significant progress across all the pipeline programs, including the initiation of a global phase 2 study and the human challenge trial with AT752 for the treatment of dengue. We are advancing this drug candidate as a potential first antiviral treatment for dengue fever. Don't forget that this is the most prevalent mosquito-borne viral disease with a large global disease burden.

These results leave us, particularly encourage that we are well positioned to meet the challenges of this global pandemic and support the next chapter of our clinical development program.

Beyond COVID-19.

We have made significant progress across all the pipeline programs, including the initiation of a global phase two study.

And the human challenge trial with 80 752 for the treatment of banking.

We are advancing this drug candidates as a potential first antiviral treatments with dengue fever.

That's we'll get that this is the most prevalent mosquito borne virus disease with a large global disease burden.

John Pierre Somodosy: Additionally, we continue preparation for the initiation of our upcoming Phase II study in Hepatitis C, evaluating the combination of two highly potent direct-acting antivirals against Hep C, Benifazvir and Rizazvir, which we recently in-licensed from Merck. I will now turn the call over to Janet to review in detail the very encouraging new clinical results for benifozbivir in COVID-19 and to provide an update on our program for the treatment of dengue and hepatitis C as well. Thank you, Jean-Pierre. Good morning, everyone.

Additionally, we continue with preparation for the initiation of our upcoming phase II study in hepatitis C. Evaluating the combination of two highly potent direct acting antiviral against F. C been forced to reveal and we were supposed to be here.

We recently.

In licensed from Merck.

I will now turn the call over to Jack to review in detail the very encouraging new clinical results hope any false movie club.

<unk> 19 and to provide and to provide an update on our program for the treatment of dengue in they put the IDC as well.

Yeah.

Thank you John good morning, everyone.

Janet Hammond: Turning to slide 4, I'll begin with the results from the Morning Sky study. As you recall, MorningSky was a randomized, double-blind, multi-center, placebo-controlled Phase 3 trial evaluating the efficacy, antiviral activity, safety, and pharmacokinetics of demiphosphobia in adult and adolescent patients with mild to moderate COVID-19 randomized in a two-to-one ratio Patients received Ida Bemley-Kosbever 550 mg twice daily or placebo for five days. As we previously announced, the study was closed out in December 2021 prior to its completion. Moving to slide five.

Turning to slide two I'll begin with the results from the morning Sky study.

Janet Hammond: Morning Sky was closed out with a sample size of 207 efficacy-evaluable patients that represented a broad patient population across both age groups and geography, with approximately 50% of patients being high risk and 50% of standard. The study enrolled 28% of patients who were already vaccinated, and 56% of the patients in the study were seropositive at baseline. The primary endpoint of the study was the time-to-alleviation of symptoms, which became particularly challenging to meet owing to the difficulty in finding a series of symptoms that are consistent across all of the variants and the population. The primary endpoint of time-to-alleviation of symptoms was not achieved in the Morning Sky study. And there was no difference in viral kinetics, which was the secondary endpoint.

As you will recall morning, Sky was randomized double blind multicenter placebo controlled phase three trial evaluating the efficacy and two of our activity safety and pharmacokinetics with it would be close to that.

Janet Hammond: With that said, hospitalization and death are currently the preferred end point by the regulatory agencies, including the FDA. And we're very encouraged that the aminophosphavir arm showed a 71% lower risk of hospitalization in comparison with placebo. In this study, Bembifostovir 550 mg BID was generally safe and well-tolerated. There were no drug-related serious adverse reactions.

Janet Hammond: Adverse Events Leading to Treatment Discontinuation were 3% for Bremnifostomere arms in comparison with 7% for placebo, and there were no GI-related events which led to treatment discontinuation. Turning to slide six. The data in the chart illustrates the key secondary endpoint of hospitalization index. As I just noted, data from MorningSky showed the risk of hospitalization was 71% lower in the Bemni-Foster-Wehr arm in comparison with placebo, with a p-value equal to 0.047, unadjusted and excorated.

Janet Hammond: We're very encouraged by this outcome, especially because of the broad population studied, and the results were consistent in both the standard and the high-risk groups. It's worth noting that other direct-acting antivirals have demonstrated a reduction in hospitalization in predominantly unvaccinated high-risk patients.

Adult and adolescent patients with mild to moderate COVID-19 randomized in a two to one ratio.

Janet Hammond: So the achievement in this broader group of patients makes this efficacy result particularly robust. Turning now to results from our Phase 2 study of high-risk hospitalized patients, on slide 7. The global phase two trial in the hospital setting was a randomized double-blind placebo-controlled multi-center study to evaluate bemifospovir in patients with moderate COVID-19. Study objectives were to assess safety, tolerability, and clinical and antiviral efficacy. Patients were randomized within five days of symptom onset to receive either Bevin-Foster VAR 560mg twice daily or placebo BID doses for five days.

Patients received either been reconstituted out 550 milligrams twice daily or placebo for five days.

As we previously announced the study was Closeouts in December 2021 project completion.

Moving to slide five.

Morning, Sky was kicked out with a sample size of 207 efficacy evaluable patients.

Represented a broad patient population across the age groups and geographies.

With approximately 50% of patients being high risk and 50% just standard risk.

The study enrolled 28% of patients who were already vaccinated and 56% of the patients in the study what's your position as a baseline.

The primary endpoints of the study was the time to deviations symptoms, which became particularly challenging to me they're going to.

The difficulty in finding a series of symptoms, which are consistent across all of the variants and the populations.

The primary endpoint is time to alleviation of symptoms was not achieved in the morning Sky study.

And there was no difference in the viral kinetics, which was a secondary endpoint.

That said hospitalization and death, all currencies the preferred endpoints by the regulatory agencies, including the S. T. A.

And we're very encouraged.

We foster their showed a 71% lower risk of hospitalization in comparison to placebo.

In this study 70 foster that 560 milligrams B I D was generally safe and well tolerated.

No drug related serious adverse events.

Adverse events, leading to treatment discontinuation with 3% of the cost of it and comparison of the 7% for placebo.

And there were no gi related events, which led to treatment discontinuation.

Turning to slide six.

The data in the chart illustrates the key secondary endpoints hospitalization and death.

I was like just nurses.

Good morning, Sky shows the risk of hospitalization was 71% in the Bentley Fosterville in comparison with placebo with a P value equal to 0.047 Unadjusted Index Garching.

We're very encouraged with this outcome, especially because of the broad population studied.

And the results were consistent in both the standard and the high risk patients.

It was nursing that other direct acting antivirals with demonstrations of reduction in hospitalization and predominantly unvaccinated high risk patients.

So the achievement in broader group of patients makes this efficacy result, particularly robust.

Turning now to results from our phase two study of high risk hospitalized patients on slide seven.

The global Phase two trial in the hospital setting was a randomized double blind placebo controlled multicenter study to evaluate when we first event in patients with moderate COVID-19.

Study objectives were to assess safety, tolerability and clinical and antiviral efficacy.

Patients are randomized within five days of symptom onset to.

To receive either bad professed about 560 milligrams twice daily or placebo B I D. Just for five days.

Janet Hammond: The key inclusion criteria for this study were adult patients 18 years of age or older with risk factors such as obesity, diabetes, and hypertension. On slide 8, I'm pleased to report that the final analysis from the phase 2 hospitalized study in 83 high-risk patients suggests potential clinical benefits. The overall rate of disease progression was low, which had an impact on our ability to assess the primary end prognosis. For example, while the overall weight of the event was low, the progression of respiratory insufficiency was 7.5% for BF in comparison to 10% on placebo. The respiratory events associated with progression were less severe in benbifost-severe treated patients in comparison with those receiving placebo.

The key inclusion criteria for this study, but adult patients 18 years of age or older with risk factors, such as obesity diabetes and hypertension.

On slide eight and keeps reports at the final analysis from the phase two hospitalized Duffy in H treat high risk patients suggest potential clinical benefits.

The overall rate of disease progression was news, which had an impact on our ability to assess the primary endpoint.

Well the overall wages adventures due the progression of respiratory insufficiency was seven 5% with them at Fosterville and comparison with 10% on placebo.

The respiratory events associated with progression, but less severe in the Bambi foster they're treated patients in comparison with those receiving placebo.

Janet Hammond: Notably, in this study, there were no deaths in patients receiving benmofosfir in comparison with three deaths reported in the placebo line. I'm pleased to report that the final virology results were consistent with the previously reported interim data. In this study, benlifostavir was generally safe and well-tolerated, with no drug-related serious adverse events, and there were no adverse events leading to treatment discontinuation.

<unk> in this study there were no deaths in patients receiving them the phosphate in comparison with three deaths reported in the placebo arm.

I'm pleased to report that the final virology results were consistent with the previously reported interim data.

In this study the foster there was generally safe and well tolerated with no drug related serious adverse events and there were no adverse events leading to treatment discontinuation.

Janet Hammond: Our overall assessment of the new data reported today suggests clinical benefits for benzosphere at 550 milligrams BID in the treatment of COVID-19. We're planning to present the full results of the MorningSky trial and the Phase 2 hospitalized study at an upcoming scientific meeting. Turning to slide 9.

Our overall assessment of the new dose or reports.

Suggest clinical benefits have been close to that 550 milligrams B I D. In the treatment of COVID-19.

We're planning to present, the full results of the morning Sky trial and the phase two hospitalized study at an upcoming scientific meeting.

Turning to slide nine.

Janet Hammond: We were very encouraged by new data demonstrating 8511, which is the free base of Bemlich-Osterville, remains fully active against the Omicron variant. As previously reported, AC511 is a potent inhibitor of SARS-CoV-2 in vitro and has previously demonstrated antiviral activity against all variants of concern, including alpha, gamma, epsilon, and delta. I can outline our next steps for the Beverly Foster Care COVID-19 Clinical Development Program. We believe that the Morning Sky results we announced today have the potential to accelerate our COVID-19 program, with 207 patients valuable for efficacy.

We were very encouraged by new data demonstrating 85 in Devon pushes the freebase to them the cost of debt remains fully active against the omicron variant as previously reported 80 511 is a person can inhibit Sars cov two in vitro and she has previously demonstrated antiviral activity against all their concern.

Including Alpha Gamma Epsilon and Delta.

Slide 10 outlines on next steps towards phosphate COVID-19 clinical development program.

We believe that the morning Sky results, we announced today have the potential to accelerate how COVID-19 program.

With 207 patients Evaluable for efficacy the size of the morning Sky studies in the range of a phase two study and.

Janet Hammond: The size of the Morning Sky study is in the range of a Phase 2 study, and as a result, we are no longer planning to conduct the Phase 2 monotherapy outpatient study that was discussed in the first quarter of this year. Based on the data he gave, Bemuel Phosphazare 550 mg BID is efficacious, generally safe, and well tolerated, and has a favorable GI tolerability. In addition, And there is no dose adjustment necessary for co-administration with drugs that are CYP3A substrates since there is a low risk of drug-drug interaction.

As a result of it no longer planning to conduct the phase two monotherapy outpatient study such as this.

Discussed in the first quarter of this year.

Based on the days of days then we've got about 550 milligrams B I D as efficacious Gen.

Generally safe and well tolerated and has a favorable Gi tolerability profile.

In addition, they move fast with that is non user journey and noncash, Virginia, and there was new Jersey adjustments necessary for co administration with drugs that are sub three eight substrates. Since there was a nervous of drug drug interactions and they're also knows Joe or country indications.

Janet Hammond: And there are also no steroid contraindications. We're pursuing regulatory interactions in the near term to review our data package for remdesivir and to discuss the next steps in the clinical program for COVID-19. Turning now to our Dengue Fever Program. As noted on slide 12, we've initiated a randomized phase 2 proof of concept study in patients with dengue fever. The study is designed to assess antiviral activity, safety, and pharmacokinetics of multiple doses of AT752, with a primary endpoint of a change in dengue virus viral load from beta. AC752 or placebo will be administered early for five days in up to 60 patients with dengue infection who present within 48 hours of a fever.

But pursuing regulatory interactions in the near term to review our data package will then fosterville and to discuss the next steps in the clinical program for COVID-19.

Janet Hammond: We expect to report initial results from the study later in the year. We have also initiated a second Dengue study, as outlined on slide 13, which is a human challenge study in the United States. In this study, healthy volunteers are dosed with AT752 or placebo and then administered a live dose of the dengue virus.

Turning now to our dengue fever program.

As noted on slide 12, we've initiated a randomized phase two proof of concept study in patients with dengue fever. The study is designed to assist antiviral activity safety and pharmacokinetics of multiple doses of 87, two with a primary endpoint is a change in dengue virus.

No convincing.

87 times, two or placebo will be administered orally for five days and up to 60 patients as dengue infection, who presented within 48 hours of a fever.

We expect to report initial results from this study in Asia, India.

We also initiated a second dengue studies outlined on site team.

Which is a human challenge study in the United States.

In this study healthy volunteers are dosed with 87 type two or placebo and then administer the life doses dengue virus.

Subject to coach them on to sit within the highly controlled setting.

Allowing assessment of viral load in the viral kinetics between the treatment groups we.

Janet Hammond: Subjects are closely monitored within a highly controlled setting, allowing assessment of viral load and viral kinetics between the treatment groups. We anticipate results in the fourth quarter of this year. Turning now to our Hepatitis C program. As shown on slide 15, our HCV combination development plan looks very promising, and we believe that there is still room to improve on the current standard. We believe Roos, in combination with Dermifrost, provides the opportunity to create a best-in-class pan-genotypic HCV therapy.

We anticipate results in the fourth quarter of this year.

Turning now to our hepatitis C program.

As shown on slide 15, our HCV combination development plan looks very promising and we believe that there is still room to improve on the current standard of care.

We believe ruses via in combinations, Ben Foster that provides the opportunity to create a best in class Pan Genotypic HCV therapy.

Janet Hammond: We're currently manufacturing rosacea clinical trial supplies for our Phase 2 study, and we're assessing the first clinical trial design Time of Clinical Trial Exams, but expect the Phase 2 Combination Program, and anticipate starting the study in the second half of the year. Without an overview, I will now hand the call over to Andrea to review our financial information.

But currently manufactured loses JAK clinical trial supplies for our phase two study and we're assessing clinical trial design.

Kind of a clinical trial design, so I'd expect the phase two combination program.

And then and anticipate starting the study in the second half yeah.

Without further Ado I will.

Now hand, the call over to Andre to review our financial information.

Andrea Corcoran: Okay, thank you, Janet. As Jonae mentioned in her introductory remarks, this morning, we issued a press release containing our financial results for the first quarter of 2020. Statement of Operations and Balance Sheet can be found on slides 17 and 18. For the first quarter of 2022, the increase in R&D expenses in comparison to the first quarter of 2021 was primarily due to the expansion of our organization and reflected an increase in payroll and personnel-related expenses, including salaries, benefits, and stock-based compensation expense, offset by a decrease in external research and development. The increase in GMA expenses quarter over quarter was primarily due to the expansion of our organization and reflected an increase in payroll, personnel-related expenses, salaries, benefits, stock-based compensation expense, and other GMA-related expenses.

Andre Thank you Janet.

As Tony mentioned in her introductory remarks. This morning, we issued a press release containing our financial results for the first quarter of 2022 statement.

Statement of operations and balance sheet can be found on slides 17 and 18.

For the first quarter 2022, the increase in R&D expenses in comparison to the first quarter of 2021 was primarily due to the expansion of our organization and reflected an increase in payroll and personnel related expenses, including salaries benefits and stock based compensation expense.

Offset by a decrease in external research and development expenses.

The increase in G&A expenses quarter over quarter was primarily due to the expansion of our organization.

Reflected an increase in payroll and personnel related expenses salaries benefits and stock based compensation expense and other G&A related expenses.

John Pierre Somodosy: Importantly, we entered the quarter with a strong balance sheet of $705.5 million to support our clinical development program. Cash expenditures during the quarter included payment of amounts that were previously recorded as accrued expenses, including a payment to Merck in the amount of $25 million in connection with the license of Rousseffere and a payment in the amount of $10.4 million in connection with the cost share arrangement with Roe. Please recall that on our earnings call in February, we had expected to incur residual costs from Roche associated with the winding down and closure of the Moonsong, Morning Sky, and Meadow Spring trials.

Importantly, we entered the quarter with a strong balance sheet of $705 $5 million to support our clinical development programs.

Cash expenditures during the quarter included payment of amounts that were previously recorded as accrued expenses, including the payment to Merck and the amount of $25 million in connection with the license to persevere and a payment in the amount of $10 $4 million in connection with the cost her arrangement with Roche. Please recall that on our earned.

<unk> call in February we had expected to incur residual costs from rooms associated with the wind down and close out of the Moon strong morning, Sky and that.

Sprint trial, we also expect to incur certain residual costs for most in the second quarter.

John Pierre Somodosy: We also expect to incur certain residual costs from OSH in the second quarter. We are reiterating today our cash guidance with a runway through 2020. I'll now turn the call back over to Jean-Pierre for his closing remarks. Thank you, Andrea. We trust today's update was informative and conveyed our confidence and enthusiasm for our clinical programs moving forward, as illustrated in slide 20. COVID-19 continues to spread and cause mobility and mortality. And this underscores the ongoing need for better treatment options due to the limitations of current therapies, such as relapse, drug-drug interaction, potential safety and efficacy concerns, and potential for resistance.

We are reiterating today, our cash guidance with a run rate through 2025.

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

Thank you Andrea.

We trust today, a day it was informative and convey.

Talk to them.

And then choose yes for our clinical programs moving forward.

As illustrated in slide 20.

COVID-19 continues to spread and close morbidity and mortality.

This underscores the ongoing need for better treatment options due to the limitations of current therapies, such as relapse drug drug interaction potential safety and efficacy concerns and potential for resistance.

John Pierre Somodosy: The short-lived efficacy of vaccines and lack of natural immunity against Omicron variants is creating another uptick in cases globally and is expected to cause a surge in cases in the U.S. this fall and winter, as the White House has announced more than 100 million infections expected in the fall and winter of 2022-23. Given Benifaz will be a unique MOA, broad-spectrum antiviral activity against all variants of concern, and new clinical results, we believe that we can deliver a safe, non-mutagenic, non-therapogenic oral antiviral for both mono and potential combination therapy for COVID-19 regardless of the evolving variants.

The shortlist efficacy of vaccines and lack of natural immunity against or microphone variance is creating another uptick in cases globally.

<unk> is expected to cause a huge cases in the U S. This fall and winter.

The white pauses announced more than 100 million infections expected.

In the fall and winter 'twenty to 'twenty two it.

Kevin Let me first review a unique way.

Broad spectrum antiviral activity against all variance of concern and the new clinical results. We believe that we can deliver a safe not only congenic natera to Janet on <unk> for both mono and potential combination therapy for COVID-19.

Regardless of the evolving variance.

John Pierre Somodosy: The efficacy, safety, and tolerability results support the next chapter of our clinical development program as we evaluate next steps to address the current gaps in treatment. We have an exciting year ahead of us as we continue to advance our anti-viral programs to fight severe viral diseases with limited treatment options. Importantly, as Andrea shared with you, we remain well capitalized to achieve these important inflection points with a cash runway through 2025. We remain confident in our strategy and steadfast in our mission to bring access to all DAA antivirals to patients around the globe. As always, we thank you for your continued loyalty and support of Atea.

The efficacy safety and Tolerability results support the next chapter of our clinical development program as we evaluate next steps to address the current gaps in treatment.

We have an exciting year ahead of us as we continue to advance our antiviral programs to fight severe viral diseases with limited treatment options.

Fortunately.

Andrea.

<unk> shared with you we.

Mine well capitalized to achieve this important inflection points. So it was a cash runway through 2025.

We remain confident in our strategy and steadfast in our mission to bring access to O.

DAA antivirals to patients around the globe.

Always we thank you for your continued loyalty and support of <unk>.

Operator: With that, operator, we will now open the call to your questions. Thank you. At this time, if you would like to ask a question, please press star one on your telephone keypad. You may remove yourself from the queue by pressing star two.

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

Thank you at this time, if you would like to ask a question. Please press star one on your telephone keypad.

You may remove yourself from the queue by pressing star two.

Eric Joseph: We'll take our first question from Eric Joseph with J.P. Morgan. Hi, good morning. This is Hannah Onn for AERG.

We'll take our first question from Eric Joseph with JP Morgan.

Hi, good morning on for Eric Thanks for taking the questions. So just from US how do the morning Sky results in phase two hospitalized study results and inform your thinking about the dose and formulation of HQ2 weeks out of the money.

Unknown Attendee: Thanks for taking the questions. So just from us, how do the Morning Sky results and the Phase 2 Hospitalized Study results inform your thinking about the dose and formulation of AT527 moving forward? Is it still likely that you will continue to pursue a revised formulation with a potential protease inhibitor combination? And then also, why wait for input from regulatory agencies at this point rather than moving forward with a revised Phase 3 design?

George.

It's still likely that you will continue to pursue opens up revised formulation was a potential protease inhibitor combination.

And then also why wait for input from Greg agencies at this point rather than moving forward with a revised phase III design it with cash on hand currently sufficient to run the other pivotal trials. Thank you.

Unknown Attendee: Is cash on hand currently sufficient to run another Phase 3 study? Okay, so that's a lot of questions. Let's do one at a time.

Janet Hammond: Janet, if you'd like to start, make some comments on the formulation, or why not start on the clinical questions related to it? Yes, so thank you very much. Firstly, in regard to the Morning Sky dose, we're very confident that the 550 milligram BID dose of demlifosfavir is the right dose to take forward into further clinical trials.

Okay. So that's very good questions.

So let's do one other time.

Jamie if you would like to salt.

They make some comment on the formulation.

It wasn't just starts on the <unk>.

Clinical questions unrelated.

Yeah. So thank you very much so, especially in regard to the morning Sky news wet with I'm very confident the 515 milligram B I D.

And then with Fosterville and is the right dose to take forward into further clinical trials, it's it's shortened both efficacy and a good tolerability profile.

Janet Hammond: It has shown both efficacy and a good tolerability profile, and we are moving forward with an optimized formulation, which we have been testing in phase one clinical trials most recently, and we look forward to showing that data later in the year. We anticipate proceeding with both monotherapy and combination therapy with the protease inhibitor. We think it's essential to have input from the regulators as the environment continues to change, and so having their input as to how they view Comparators' standards of care, etc.

And we are moving forward with an optimized formulation.

Which we have been testing in phase one clinical trials.

Most recently and we look forward to sharing that data nature, India, We we anticipate proceeding with both monotherapy and combination therapy with the protease inhibitor.

And we think it's essential to have input from the regulators and as the environment continues to change and so having having their own protest to how they view.

Patch is standard of care sector, I think will be critical for ensuring that all study is relevant in the landscape as it continues to evolve and then with regard to the cash and I turn it back over to Andrea and J P.

Janet Hammond: I think it will be critical for ensuring that our study is relevant in the landscape as it continues to evolve, and then with regard to the cash. And I turned it back over to Andrea and Vavricka. So, just to reiterate, as Janet mentioned, we have an optimized formulation. We expect full CMC by the end of the second quarter; we have already started some phase one, as Janet indicated; we will share with the street, very likely in Q3. But we are ready to go with the new formulation, with the optimized formulation, regardless of the clinical trials that will be the next step. Andrea, do you want to comment on the cash?

So.

Just to reiterate.

Chavez mentioned.

The optimized formulation.

We expect was a full C M C.

By the end of the second quarter, we already saw some place along those travelers indicated we will share with the street.

And.

Q3 <unk>.

We are ready to go with the new formulation was the optimized formulation.

With all this.

Clinical trials that would be the next step.

Joanne you want to comment on the cash.

Andrea Corcoran: Yes, sure. The cash is more than adequate to fund the pivotal trials for COVID-19 and other programs. Great, thank you. And then, just looking towards the upcoming data presentations, can we expect variant sequencing data and potentially any additional subgroup analyses in these readouts? Yes, you can expect both variant sequencing and some subgroup analysis.

Yes sure.

Cash is more than adequate to fund our pivotal trials for the COVID-19 and other programs.

Yes.

Great. Thank you and then just looking towards the upcoming data presentations can we expect the variant and sequencing data and potentially any additional subgroup analyses and lease it up.

Janet.

Yes, you can expect them, both merit and sequencing and some subgroup analyses yes.

Okay, great. Thank you and thanks for taking the question.

Okay.

Thank you. Our next question will come from Matthew Harrison with Morgan Stanley .

Janet Hammond: Okay, great, thank you. Thanks for taking the questions. Thank you. Thank you. Our next question will come from Matthew Harrison with Morgan Stanley. Hi, I'm Steve, asking for Matthew.

Hi, I'm, Steve I'll ask a couple of my views on when I asked him further about the potential combination because you just mentioned you are going to do.

Matthew Harrison: I want to ask you further about the potential combination because you just mentioned you're going to do some PTP study. I want to ask you any other information you can give us about what potential partners you're going to collaborate with. Thank you. Well, first of all, we are evaluating ourselves some external potential in licensing, as well as internal efforts in API. So we are very happy to collaborate with any interested parties. But ultimately, our preference would be to have our own API, either through external licensing or internal efforts.

Do some PK PD study I want to ask any other color you can give us about what are the potential partners you are going to collaborate thank you.

Well.

Just first of all we are.

Right.

Ourself.

So.

Sure.

Potentially in licensing as well as internal efforts on it.

So are we.

They all IP to corroborate with any interested parties.

But ultimately our preference would be two of our own P I either so.

So in licensing or internal effort.

Okay.

Thank you. Our next question will come from Omar <unk> with Evercore.

Unknown Attendee: Okay, thanks. Thank you. Our next question will come from Umar Rafat with Evercore.

Umar Rafat: Hi guys, thanks for taking my question. And I want to start by saying congratulations on the strength of the data on hospitalization. But I guess in the same breath, I'm also a little confused. Number one, had Roche seen this data at the time it terminated the collaboration? And number two...

Hi, guys. Thanks for taking my question and I want to start by saying congratulations on the strength of the data on hospitalization.

In the same breath I'm also a little confused on a few things number one had roche seamless data at the time they terminated the collaboration.

And number two very good questions.

John Pierre Somodosy: Very good question, Uma. Roche ended up on the ship prior to the morning sky results. This was prior to. Okay, great. And then also, JP, can you speak to the pace of recruitment in the trial? Because it doesn't seem as robust as we were seeing in the Pfizer and Merck studies. And also... Yeah, it's a very good question, Umar. I'll let Janet answer the difficult question. I will answer the easy one.

Yeah.

On the fly up to the monarch Sky results.

This was prior to okay, great and then also J P. Can you speak to the pace of recruitment in the trials because it doesn't seem as robust as we were seeing in the Pfizer and Merck studies and also.

Very good question.

I'll, let Jeremy to answer the difficult questions I'll answer the easy one go ahead Jamie.

Janet Hammond: Go ahead, Janet. So Roche was responsible for the Phase 3 trial leadership and operational execution, and the recruitment was disappointing. There seemed to have been some operational issues there.

She was responsible for the phase III trial, he leadership and operational execution and and just the recruitment was disappointing that seem to have been some operational issues that.

Janet Hammond: Sites were still being opened, and enrollment was anticipated to have increased substantially in the last couple of quarters of last year, but yes, it's disappointing that there weren't more patients. Okay, and I guess the third one is in the seronegative population. How did the primary endpoint look in the seronegative population, as well as, as you think about this new trial that you're starting up, can you... Do you think you guys can wrap it up before the EUA is gone? I think that's a serious question. Janet?

Such as still being opened and enrollment was anticipated you'll have increased substantially in the last couple of quarters of last year.

But yes, it's disappointing that the rental patients.

Okay.

The third one is in the zero negative population how did the primary endpoint look into seronegative population as well as you think about this new trials that youre starting up can you do you think you can wrap it up before the EUA is gone I think that's a real question.

Janet.

So we're going to present the southern Odyssey.

Janet Hammond: So we're going to present the sub-analyses at a scientific meeting later in the year. So I'm afraid I'm going to leave you on the edge of your seat with regard to that one. And I don't know about the EUA and how long that's likely to be around.

Scientific meeting data in the App search I'm afraid I'm going to leave you on the integral seat with regard to that one and Oh I don't know about the EUA and how long that's likely to be around so we'll have to see but we hope to go as fast as we can.

Janet Hammond: So we'll have to see, but we hope to go as fast as we can. Okay, thank you very much. I'll be in touch with some more.

Umar Rafat: Thank you guys. Thank you, Emma. Thank you. Once again, if you would like to ask a question, please press star one on your telephone keypad. Our next question will come from Tim Lugo with William Blair. Hi, this is John. I'm for Tim.

Okay. Thank you very much I'll be in touch with them more thank you guys.

Okay.

Thank you once again, if you would like to ask a question. Please press star one on your telephone keypad.

Our next question will come from Tim Lugo with William Blair.

Timothy Lugo: Thanks so much for taking our question and congratulations on the new data. So I was just wondering, given the availability of other oral antivirals, how you're thinking and looking at how feasible it will be to enroll a phase three study, even with supply constraints out there, and what strategies you are looking at. Sure. Janet, can you address the question, please?

Hi, This is John on for Tim. Thanks, So much for taking my question and congrats on congrats on the new data.

Just wondering given the availability of other oral anti virals, how youre thinking and looking at how feasible it will be to enroll a phase III study.

With supply constraints out there and what strategies are you looking at to enroll the study.

Sure Janet can you address the question please.

Janet Hammond: So, we're cognizant of the landscape, but as Jean-Pierre mentioned, the White House is indicating that they're anticipating perhaps up to 100 million infections this coming fall and winter. And certainly, the virus seems to show no evidence of going away. So we think there are going to be plenty of patients out there. And we believe that Bendifrostivir has considerable advantages over the current existing direct-acting antiviral.

Sure well, we're cognizant of the landscape and I think as jump you had mentioned I'm here with the white house's, indicating that that they're anticipating perhaps up to 100 million infections. This coming fall and winter and patently. The virus seems to show no evidence of going away. So we think that going to be plenty of patients out there and we can.

The fact.

Then the Fosterville has considerable advantages over the current existing direct acting anti viral so we certainly see a role for it.

Janet Hammond: So we certainly see there is a role for it. It's really going to be a question of discussing with regulators how best to design a study that is going to be suitable to demonstrate what it can do. And we look forward to talking to them very shortly. Okay, great. And maybe just one follow-up.

It's it's really going to be a question of discussing with regulators how best to design.

A study that is going to be suitable.

To demonstrate what it can do and and we look forward to talking to them and very shortly.

Okay, Great and maybe just one follow up so given the strength of the data for <unk> do you think you'd have more leverage to go potentially future external partner for a combination study.

John Pierre Somodosy: So given the strength of the data today, do you think you have more leverage to potentially seek an external partner for a combination study? Well, as I said, John, we welcome any potential interest. But it's clear that we will favor internal PI. We are evaluating several external opportunities as we speak, and some more advanced than others.

Well as I said.

John .

We welcome.

Potential interest.

But it's clear that we.

We would say the inter.

Internal.

We are evaluating actually several.

External opportunities as we speak.

And.

Some more advanced than Aldo.

John Pierre Somodosy: And also, we have some interesting data from the internal efforts that we will definitely share with the street before the end of the year. Our goal with those efforts is to generate a best-in-class PI. I know that this is a buzz word.

Also we have some interesting data from.

From the total households that could definitely we share with the street.

Before the end of the year I would go with those air filters are used to generate.

Best in class B I know that this is a buzzword, but we believe there is quite some room, if it does or lost I like Jonathan.

John Pierre Somodosy: But we believe there is quite some room for those of us like Janet and me who have actually actively involved with PI both in the HIV and the HCV world. We would like to see PI sub-nanomole potency with long off-rate rather than quick off-rate like the Pax-Lorid, which may lead to relapse, as you know. Okay, great. Thanks again and congrats on the data.

Oh actually actively we're actively involved with Spi grocery the HIV and HCV was we will like to CPI shutting down no more potency.

With rank our plate rather than a quick way to like Oh.

Black Swan, which may lead to two relapses.

No.

Okay, great. Thanks, again, and congrats on the data.

Gotcha.

Thank you. Our next question will come from ROE on a ruler with S V B Securities.

Timothy Lugo: Thank you. Thank you. Our next question will come from Irowana Ruiz with SVB Securities. Hi, good morning. This is Nick Jacek from Rwanda.

Hi, Good morning. This is Nick <unk> on for Walter Thanks for taking our questions I guess I'll start with COVID-19, though you talked a bit about design considerations for upcoming trials I'm just curious.

Irowana Ruiz: Thanks for taking our questions. I guess I'll start with COVID-19. I talked a bit about design considerations for upcoming trials. I'm just curious, is assessing hospitalizations and deaths still a feasible endpoint at this stage, given the evolving landscape? And would you consider using locally available treatments like together with Ben the Foster, Ben the Foster year in future trials? Yeah.

[noise] hospitalizations and deaths still a feasible and point at this stage given the evolving landscape and would you would you consider the use of locally available treatments like together with boneless fostered by the fasten your future trials.

Janet.

Janet Hammond: So unfortunately, yes, we believe that hospitalisation and death are still endpoints. I think, as you know, there's been varied uptake of the vaccine. Then, of course, there are some patients who, in spite of being vaccinated, don't generate an adequate immune response. So in particular, the high-risk groups of patients, we believe, are the place where hospitalisation and death will continue to be a problem.

So unfortunately, yes, we believe that hospitalization and deaths are still endpoints I think and as you know that's been varied uptake of the vaccine and then of course, there are some patients who in spite of being vaccinated don't generate adequate immune response in particular the high risk.

Groups of patients. We believe are Paceway hospitalization definitely continues to be a problem.

Janet Hammond: So that's really, I think, going to be the primary focus of where we're going to be going. And then certainly, yes, I think any treatment that we provide in the context of a clinical trial will need to be at the top of the best available standard of care. And that, of course, does increase the sample size, but it's going to be important. But we look forward to talking this all through with the regulators and being certain we have a good study design. I got it.

So that's that's where do you think that's going to be the primary focus of how we're going to be going and then secondly, yes, I think any treatment that we provide.

In the context of a clinical trial will need to be on the top of the best available standard of care and that of course does increase the sample size, but it's going to be important but we look forward to talking this all through with the regulators in being second we have a good study design.

Irowana Ruiz: And just on dengue with 7-5-2, could you could you discuss your rationale for challenging patients with the dengue virus after they receive 7-5-2 as opposed to waiting, like, a certain period of time to administer treatment? And maybe just how many days after they've received 7-5-2 are patients being challenged? So the patients are challenged within 24 hours of being given 7-5-2, but I think the purpose of the study is more of a pre-exposure, a prophylaxis study, not a pre-exposure, just a prophylaxis study, which I think is a very good way of demonstrating the activity of the drug in that patient population.

Got it.

And just on dengue with 752 could you could you discuss your rationale for challenging patients with the dengue virus. After they received 752 as opposed to waiting.

The period of time to administer treatment and then maybe just how many days after they've received seven five to.

Are patients being challenged.

Cause the patient challenged within 24 hours of being different seven type two but I think the purpose really of the studies move up.

Pre exposure.

Right.

The person next to studying pre exposure prophylaxis study, which I think is a very good way of demonstrating the activity of the.

The drug in that patient population, it's challenging to them.

Irowana Ruiz: It's challenging to get patients who have dengue fever in the window in which I think there is the maximal opportunity of demonstrating an antiviral effect. And so we believe that this is a nice shortcut, really, to being able to see proof of the mechanism of the drug in the viral infection. And so we look forward to doing this study in prophylaxis, as well as doing a study looking at different doses, a dose finding study in patients with dengue out in the field. So I think with both, we have a pretty robust phase two program. I got it.

Patients who.

<unk>, who have dengue fever.

In the winter in which and I think that was the next node opportunity of demonstration antiviral effect and so we believe that this is a nice shortcut to ready to being able to see proof of mechanism.

In the virus infection until we report during the study and personal axis as well as doing a study looking at the different doses and dose finding study in patients with dengue out in the field. So I think we first we have a pretty robust phase two program.

Janet Hammond: And then just one more for me on dengue, this time for the proof of concept. Are you planning to roll on higher-risk patients with comorbidities in this trial? What's the therapeutic window like for an antiviral like 752? And maybe what are you hoping to learn from this trial?

Got it and then just one more for me on dengue. This time for the proof of concept or are you planning to roll on high risk patients with Comorbidities in this trial, what like what's the therapeutic window like for an antibody like some fun to and maybe what are you hoping to learn from this trial like what.

What magnitude of viral load reduction would be clinically meaningful.

Janet.

Janet Hammond: Like what, what magnitude of viral load reduction would be clinically meaningful? Thank you. So I think what we hope to see is that patients who are treated early are able to avoid developing a cytokine storm, which is what happens with dengue fever. And I think, obviously, the change in the viral load depends, to some extent, on where you start. But we hope to see that we are able to reduce viral loads to close to undetectable pretty shortly, and the window for treatment is generally within about 48 hours of the onset of infection. So it's a pretty short window, but people get sick pretty quickly.

Well I think I think and what we hope to see is that patients who are treated early and are.

Are able to avoid and developing a cytokine storm, which is what what happens with dengue fever.

And I think obviously the the.

And changing the BARDA it depends to some extent on how your stock, but we hope to see that we are able to reduce viral loads to undetectable could you. Shortly and then the window for treatment is generally within about 48 hours of the.

The onset of infection. So it's it's a pretty short window that people get pretty quickly. So we hope that they'll and we'll be able to identify and treat them within that time period.

Janet Hammond: So we hope that we'll be able to identify and treat them within that time period. Great. Thank you very much, Janet. Thanks for taking our questions. You're welcome.

Great. Thank you very much John and thanks for thanks for taking our questions.

You're welcome thank you.

Irowana Ruiz: Thank you. Thank you. Our next question is a follow-up from Umar Rafat with Evercore. Hi guys, this is actually John.

Thank you our next question is.

Follow up for Omar robot with Evercore.

Umar Rafat: I figured I'd hop on and ask as well. I was going to ask another follow-up question about Dengue, actually. And I'm thinking about the next steps in development there. Of the two trials you're running, what are the key endpoints for advancement in this program? And do you think it's going to be easier to demonstrate a virological benefit for Dengue than it has been? Uh, Janet?

Hi, guys. This is actually John I figured I'd hop on and ask as well I was going to ask another follow up about the dengue actually and I'm thinking about the next steps in development. There of the two trials you're running what are the key endpoints for advancement for this program and and do you think it's going to be easier to demonstrate.

Virological benefit for dengue other than it has been for Covid.

Janet.

Okay.

Janet Hammond: So I think, I think what we want to be able to show is that we have a well-tolerated and efficacious drug that is able to drop viral loads to the point where we obtain those clinically meaningful benefits for patients. And we think we should be able to see that, or at least get a glimpse of what that should look like in this initial study. And we're very confident from the animal models that we do have a highly efficacious drug for dengue fever and probably for other flavor viruses also.

See I think I mean, I think what we want to be able to show is that we have a well tolerated.

And efficacious drug, but she's able to drop found its to the point, where we obtain a clinically meaningful benefit to patients and we think we should be able to see that and at least get a glimpse of what that should look like in this initial study.

And went.

But you know we're very confident from the animal models that we do have a highly efficacious drug for dengue fever, and probably for other favorite viruses Olson, but and you know the the proof of the putting would be in what we see in the upcoming study and I think it will evolve and understanding as we move through those trials.

Janet Hammond: But the proof of the pudding will be in what we see in the upcoming study, and I think it will evolve in our understanding as we move through this trial. Just to add an additional comment, John, I think the major difference between CARBID and Dengue regarding virology is that you have a viremia, whereas Dengue, as Janet has indicated, we have seen decreased viremia in the small animal model.

Just to add an additional comment John .

The major difference.

Part of it.

And dengue regarding virology is that you have is like an email with dengue.

China has indicated we have C diff.

Decreased viremia and the small animal model.

I think the challenge, especially with Nick for Cabot, and well 92 bonds demonstrated antiviral activity is that you mentioned there was no value EMEA as you know John .

John Pierre Somodosy: I think that the challenge, especially with NERC for CARBID and demonstrating anti-viral activity, is that there is no viremia, as you know, John, and you're measuring the viral load in the nasal pharynx, which very likely does not reflect where you have the major issue in terms of clinical effect, which is in the lung with CARBID. So that's where you do kind of an extrapolation from one organ to another, and definitely, we believe because of the mechanism of action, and you see the same with Remdesivir, we are looking at some models, John, now that hopefully we will be able to address this difference in terms of lack of anti-viral activity in the nasal pharynx.

And you are measuring in the nasopharynx.

Oh loads.

Very likely does not reflect well you have the major issue in terms of clinical effect, which is in the lungs with Cabot. So that's where you do a kind of a.

L a and extrapolation from from one Olga to Anoro and.

Definitely we.

We believe because of the mechanism of faction and you'll see the same wisdom disappear.

We're looking some in vitro models John now that.

Believe we will be able to to address this difference in term of a lack of citywide activity and the Nashville phase I at least wanted to see like US is consistent because we have demonstrated antiviral activity.

John Pierre Somodosy: At least, when I say lack, it is inconsistent because we have demonstrated anti-viral activity, as you know, in a hospitalized patient. We have also shown anti-viral activity in a high-risk patient in the Moonsound with the infectivity assay, the infectivity virion assay, but it's inconsistent, and so we are looking to try to figure it out a little bit with some in vitro systems. We have some hypotheses that we try to evaluate. But ultimately, what you want, obviously, is clinical benefits, as we have demonstrated with Benifazbivir, even in a very broad patient population, as I'm sure you can appreciate that, believe that we are the first one to do so in 50% low-risk, 50% high-risk, and vaccinated individuals, which is more the reality today as compared to previous studies with other D

No you know, Oxford the life Ah patients, we have shown wholesaling to you about activity and Uh huh.

Hi, with station in one song was the Infectivity USA.

Yeah its activity.

And I'd say, but it's inconsistent and so we are looking to us to try to figure out a little but.

With some some in vitro systems, we have somebody Plaza Soc that we're trying to as I do that right now.

But ultimately what you want obviously its clinical benefits as we have demonstrated was then at fosterville, even in a very broad patient population as I'm sure you can appreciate all that.

Believe that we have the first one.

At a 50% 50% high risk.

Actually individual which is more the reality today as compared to our.

Previous studies with <unk>.

John Pierre Somodosy: Thank you. This concludes the Q&A portion of today's call. I would now like to turn the call back over to Jean-Pierre Samadosi for any additional or closing remarks. Again, thank you so much for your attention and thank you for joining us today. This concludes today's Atea Pharmaceuticals first quarter 2022 earnings call and webcast. You may disconnect your lines at any time.

Thank you. This concludes the Q&A portion of today's call I would now like to turn the call back over to shop here, some adobe for any additional or closing remarks.

Again, thank you so much for your attention and thank you for joining us today.

This concludes today's Acadia pharmaceuticals first quarter 2022 earnings call and webcast. You may disconnect. Your lines at any time have a wonderful day.

Operator: Have a wonderful day...

Thank you.

Okay.

Okay.

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Okay.

Okay.

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