Q2 2022 Atea Pharmaceuticals Inc Earnings Call
Okay.
Unknown Executive: Good afternoon, ladies and gentlemen.
Good afternoon, ladies and gentlemen, welcome to the Teva Pharmaceuticals second quarter 2022 financial results Conference call. At this time, all participants are in a listen only mode.
Unknown Executive: Welcome to the Atea Pharmaceutical's second quarter 2022 financial results conference call.
Unknown Executive: At this time, all participants are in a listen only mode.
Following the formal remarks, we will open the call up for your questions.
In order to ask a question you will need to press star one one on your telephone.
You will then hear an automated message advising that your hands raised.
Please note that today's conference is being recorded I would now.
Now I'd like to turn the call over to Janet Barth Senior Vice President of Investor Relations and corporate communications at a chair Pharmaceuticals. Please proceed.
Unknown Executive: Following the formal remarks, we will open the call up for your questions.
Good afternoon, everyone and welcome to Acadia Pharmaceuticals second quarter 2022 financial results Conference call earlier today, we issued a press release outlines the topics. We plan to discuss you can access the press release as well as the slides that we'll be reviewing today by going to the investors section of our website.
Unknown Executive: In order to ask a question, you'll need to press star one one on your telephone, and you'll then hear an automated message advising that your hand is raised.
At IR I'd tell you pharma dot com and go to the events and presentations section with me today from our Chief Executive Officer, and founder Dr. John <unk>, Chief Development Officer, Dr. Janet Hamon, Chief Financial Officer, and Executive Vice President of legal Andrea.
Unknown Executive: Please note that today's conference is being recorded.
Our Chief commercial Officer John's Africa, They will all be available for the Q&A portion of today's call.
Before we begin the call.
And on slide two I would like to remind you that today's call will contain statements.
Statements that involve risks and uncertainties. These risks and uncertainties are outlined in today's press release and in the company's recent filings with the Securities and Exchange Commission, which we encourage you to read our actual results may differ.
From what is discussed on today's call.
With that I'll now turn the call over to John here.
Unknown Executive: I would now like to turn the call over to Jonae Barnes, Senior Vice President of Investor Relations and Corporate Communications at Atea Pharmaceuticals.
Thanks Julien.
I wanted to thank you for joining us today.
To start with I hope any thoughts of your program, where there was much to report so as you can see summarized on slide.
Jonae Barnes: Please proceed.
It is now evident that as detailed on slide four nine.
Jonae Barnes: Good afternoon, everyone, and welcome to Atea Pharmaceutical's second quarter 2022 financial results conference call.
Jonae Barnes: Earlier today, we issued a press release that outlines the topics we plan to discuss.
19 wheel, we wanted to be remain a global approach concern for very long time, Indeed, we see new variance in some variance emerging in shorter time intervals and the <unk>.
Rate of infection is increasing.
Jonae Barnes: 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 irateafarma.com and go to the events and presentation section.
The change in characteristics of cars, the existing antibody treatment to fail and that reduced the efficacy vaccine induced immunity, creating the need for frequent and normally engineered booster to combat the American variant.
Jonae Barnes: With me today from Atea, our Chief Executive Officer and Founder, Dr. John Pierre Semidossi, Chief Development Officer, Dr. Janet Hammond, Chief Financial Officer and Executive Vice President of Legal, Andrea Corcoran and our Chief Commercial Officer,
Jonae Barnes: John Bavarica.
Jonae Barnes: They will all be available for the Q&A portion of today's call.
Jonae Barnes: Before we begin the call,
Pandemics.
Can be life threatening good does that high with over 65 years old.
Currently does with briefs factors, causing increase of utilization in depth right.
Jonae Barnes: I would like to remind you that today's discussion will contain
Right now.
Five accounts for the vast majority of infections is IV infectious and new variance expected to fuel its search at this fall.
Jonae Barnes: 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.
New enrollments evolves with improved profiles.
Urgently needed.
The limitations of the current density of our treatment options.
Jonae Barnes: Our actual results may differ from what is discussed on today's call.
Limitations include the issue of relapse.
Which was experienced by both president of embodied in that 'twenty policy. Among those taking packed lauder relapse can lead to a rebound of symptom as well as transformation of infection through all this.
Although limitations include drug drug interactions with many commonly prescribed lifesaving drugs.
This drives the frequency of use amongst those.
Most vulnerable to COVID-19, limiting the ability for practice will obviously be prescribed and raising treatment dilemna patients and prescribers.
With Brittany cost review.
Have the potential to address many of these limitations.
We are working diligently to deliver improvements, although the current standard of care.
Moving to slide five.
We recently had an end of phase II meeting with the FDA and Matt with the European Medicines Agency emerging task force to review of the Binney, causing real data package today, including the morning Sky results. Let me remind you that in the morning Sky study, which we reported in.
May the risk of recapitalization with 71% lower in the Binney first review of 550 milligram PID.
It's just placebo with a P value equal to 0.047.
Adjusted an explosively.
Obviously, we are very encouraged with this outcome and the results were consistent in both standard and the high risk patients as well.
We are now in the process.
Finalizing the design.
Hi.
Robert.
Clinical trial for the treatment of mild to moderate.
Yes.
Drawn.
Any progress on that.
15 milligram dose twice daily for five days in the high risk patients, including those who are immunocompromised, regardless of vaccination status there.
The primary endpoint will be asked utilization.
Operational planning is currently underway for this global trial and we expect to initiate this study in the fourth quarter of this year.
Turning to slide six.
We are confident.
Cost review will remain fully active against future variance.
This is Ben on the consistent.
<unk> antiviral activity that we continue to generate new variance of concerns and Merck.
Awesome.
Our most recent data set.
Antiviral activity against or Micron, so variance similar to the potency demonstrated with alpha beta and gamma Epsilon and Delta.
These data reinforce.
Understanding.
It was to be a potent inhibition of the two functional domains of the highly conserved viral RNA protein noise.
We remind you that details related to the molecular mechanism published in nature Communications earlier this year.
Moving to slide seven.
Based on the evolving nature of COVID-19 games.
Unmet medical needs.
We are pursuing.
A multi pronged approach with place us at the forefront of the wood.
Wrapping a combination regimen.
The treatment gaps probably 19.
In the future, we see a role for <unk> as monotherapy.
<unk> combination regimen.
Right now its previously not bid.
There are treatment gap.
Generation protease inhibitors, including drug drug interactions and relapse or Odessa.
Also we can anticipate resistance will emerge with broad use prolonged treatment and treatment when cortez.
But <unk> inhibitors are administered as a monotherapy.
Where is there any possibility of chartering profile, we believe that it has the potential to become the cornerstone therapeutic co both monotherapy and in combination therapy.
Our rationale for pursuing in parallel to our late stage monotherapy trial.
A second generation <unk> inhibitor with an improved profile to be used in combination with <unk> in spirit.
<unk> patient population.
On slide eight.
Part of this effort.
Our target profile for <unk>.
Second generation protease inhibitors.
Highly potent drug.
A good safety profile with limited drug drug interaction.
It's not the required return on it.
The booster.
And I am pleased to report today.
We have made significant progress.
With our internal program.
Indeed.
In a short time period.
We have achieved two essential properties with potency.
None of the mall and sub 90 memorial levels and good.
<unk> stability, leading to a highly promising compounds.
We are now working to combine this potency and metabolic stability and a clinical candidate.
Oh.
Select later this year.
Moving to slide nine.
The antiviral effect of <unk> <unk> and <unk>.
You mentioned was the quota is significant part of it.
In vitro and edge kind of 50 to 90 days for a good model and.
The results indicate.
Additive currency valid construct.
So not only we are encouraged by these data.
These data support the potential benefit of a combination of any progress here with the protease inhibitor for the treatment of COVID-19.
John Pierre Semidossi: With that, I'll now turn the call over to John Pierre.
I will turn the call over to Janet.
We view <unk>.
Fever, and hepatitis C progress.
John Pierre Semidossi: Thank you, Janet.
<unk>.
John Pierre Semidossi: Good afternoon, everyone, and thank you for joining us today.
Thank you John turning to slide 11.
John Pierre Semidossi: I would like to start with our many parts of your program, where there is much to report, as you can see summarized on slide three.
John Pierre Semidossi: It is now evident that, as detailed on slide four, COVID-19 will likely remain a global health concern for a very long time.
John Pierre Semidossi: Indeed, we see new variants and sub-variants emerging in shorter time intervals, and the rate of infection is increasing. The changing characteristics have caused the existing antibody treatment to fail and have reduced the efficacy of vaccine-induced immunity, creating the need for frequent and newly engineered boosters to combat the emerging variants.
Begin with a review of our program to treat thank you Susan.
John Pierre Semidossi: Pandemic surges can be life-threatening to those at high risk over 65 years old, particularly those with risk factors causing increased hospitalization and death. Right now, BA5 accounts for the vast majority of infections. These early infections and new variants are expected to fuel a surge this fall.
And recently hundreds of thousands of cases of dengue has been posted across southeast Asia and to the flooding and the climate issues experienced staff.
In the United States in Miami Dade County.
Mosquito borne illness advisor was issued for dengue in late July after the first case was confirmed this year in Florida.
There are no treatment. Thank you.
Thank you is the most prevalent mosquito borne viral disease.
Almost 400 million individuals on an annual basis.
Thank you and then making over 100 countries and more than half the world's population is at risk right.
John Pierre Semidossi: New oral antivirals with improved profiles are urgently needed due to the limitations of the current antiviral treatment options.
There is a significant unmet medical need.
John Pierre Semidossi: These limitations include the issue of relapse, which was experienced by both President Biden, and Sonny Fauci, among others, after taking paclavin.
John Pierre Semidossi: Relapse can lead to a rebound of symptoms, as well as transmission of infection to others.
John Pierre Semidossi: Other limitations include drug-drug interactions with many commonly prescribed life-saving, drugs.
The global economic burden is estimated to be between 8% to $9 billion annually.
John Pierre Semidossi: These drugs are frequently used among those that are the most vulnerable to COVID-19, limiting the ability for paclavin to be prescribed and raising treatment dilemmas for patients and prescribers.
John Pierre Semidossi: With Benifaz-Breville, we have the potential to address many of these limitations, and, we are working diligently to deliver improvements over the current standard of care.
John Pierre Semidossi: Moving to Slide 5, we recently had an end-of-Phase II meeting with the FDA and met with the European, Medicines Agency Emerging Task Force to review the Benifaz-Breville data package to date, including the MorningSky results. Let me remind you that in the MorningSky study, which we reported in May, the risk of hospitalization, was 71 percent lower in the Benifaz-Breville 550 mg BID arm versus placebo, with a p-value equal to 0.047, unadjusted and exploratory.
As noted on slide 12.
John Pierre Semidossi: Obviously, we are very encouraged with this outcome, and the results were consistent in, both standard and high-risk patients as well.
John Pierre Semidossi: We are now in the process of finalizing the design of a global, late-stage clinical trial, for the treatment of mild to moderate COVID-19, trying to evaluate Benifaz-Breville 550 mg dose twice daily for five days in high-risk patients, including those who are immunocompromised regardless of vaccination status. The primary endpoint will be hospitalization and death.
We continue to enroll patients in the defense two trial, which is a randomized phase two proof of concept study in patients with dengue fever.
John Pierre Semidossi: Operational planning is currently underway for this global trial, and we expect to initiate, this study in the fourth quarter of this year.
The study is designed to assist antiviral efficacy safety and pharmacokinetics of multiple doses of Ags <unk> with a primary endpoint of change in dengue virus found the baseline.
87, <unk> or.
Or placebo will be administered R&D for five days and up to 60 patients with dengue infection.
We expect to report initial results from this study later EMEA.
We also initiated our questions. Thank you study.
As a human challenge model in the United States.
In this study healthy volunteers logistic AC circumcised too okay.
And then administer utilizes the thank you Scott.
The subject of Turkey monitors within a very controlled person.
Allowing for the assessment of <unk> and the viral kinetics between the treatment groups.
We also expect to report the preliminary results from this study.
Turning now to our hepatitis C program.
John Pierre Semidossi: Turning to slide six, we are confident that Benifaz-Breville will remain fully active, against future variants. This is based on the consistent potent antiviral activity that we continue to generate as new, variants of concerns emerge and are tested. Our most recent data set confirms antiviral activity against omicron surveillance, similar, to the potency demonstrated with alpha, beta, gamma, epsilon, and delta. This data reinforced our understanding of Benifaz-Breville potent inhibition of the, two functional domains of the highly conserved viral RNA polymerase. Let me remind you that details related to the molecular mechanism were published in, Nature Communications earlier this year.
John Pierre Semidossi: Moving to slide 7, based on the evolving nature of COVID-19 variants and unmet medical needs, we are pursuing a multi-pronged approach, which places us at the forefront of developing a combination regimen to fill the treatment gaps of COVID-19.
John Pierre Semidossi: In the future, we see a role for beniphosphazine as monotherapy, as well as in combination regimens.
As shown on slide 14.
HCV combination development plan looks very promising.
John Pierre Semidossi: Right now, as previously noted, there are treatment gaps with first-generation protease, inhibitors, including drug-drug interactions and relapse of the symptoms.
And we believe that there is still room to improve upon the standard of care for hepatitis C.
HCV combination profile includes convenient central treatment duration with the potential for this test drive of Iron free therapy for Decompensation, Inc.
We believe recent yet in combination with them with us today.
The opportunity to create a best in class Pan Genotypic HCV therapy.
But continuing to make progress with our program and have completed the required combination preclinical toxicology study.
We are currently manufacturing loses their clinical trial supply.
And are finalizing the phase II clinical trial design.
We expect the phase two combination program to evaluate convenient short treatment durations in those non cirrhotic and compensated patients with cirrhosis.
We anticipate initiating the study later this year.
With that I will now hand, the call over to Andrea to review our financial information.
Thank you Janet.
Your name mentioned in her introductory remarks earlier today, we issued a press release containing our financial results for the second quarter of 2022.
Many of operations and balance sheet on slide 16 and 17.
For the second quarter 2022, the decrease in R&D expenses comparison to the second quarter of 2021 was driven principally by the discontinuation of our cost share arrangement with Roche is cost share arrangement fees when the collaboration with Roche ended earlier this year.
The decrease was partially offset by an increase in R&D employee payroll and personnel related expenses.
The nominal increase in G&A expenses in the second quarter 2022 over the second quarter 2021 was primarily due to an expansion of our organization and reflects an increase in payroll and personnel related expenses.
We ended the quarter with a strong balance sheet, including cash resources in the amount of $684 $5 million to support our clinical development programs.
Cash expenditures during the quarter were $21 $1 million.
We are reiterating our cash guidance with a runway through 2025.
I'll now turn the call back over to Sean <unk> for closing remarks.
Thank you Andre.
Sure the first half of 2022.
John Pierre Semidossi: Also, we can anticipate resistance to emerge with broad-use, prolonged treatment, and re-treatment, when protease inhibitors are administered as monotherapy.
John Pierre Semidossi: With beniphosphazine's attractive profile, we believe that it has the potential to become, the cornerstone therapeutic for both monotherapy and in combination therapy.
Considerable progress advancing all antiviral platform, who is the ATM.
We're transforming the treatment of severe viral diseases.
Global demand for COVID-19 treatments continue and that data we remain confident in the opportunity for it.
To deliver a multi pronged approach with best in class all antivirals to treat COVID-19 variance as the virus continues to evolve.
On slide 19.
As we look to the balance of the year.
We expect to build on this momentum by achieving a number of value, creating milestones, including the initiation of our late stage clinical trial with many positive for Covid.
<unk> 19 <unk>.
Reporting preliminary clinical data from our dengue fever program.
The initiation of our phase two combination program in HCV. In addition, our goal is to select the second generation protease inhibitor critical candidate for COVID-19.
John Pierre Semidossi: This is our rationale for pursuing, in parallel to our late-stage monotherapy trial, a second-generation, protease inhibitor with an improved profile to be used in combination with beniphosphazine in specific patient populations. On slide 8, as part of this effort, our target profile for a second-generation protease inhibitor, is a highly potent drug that has a good safety profile with limited drug-drug interaction and does not require ritonavir or any other booster.
John Pierre Semidossi: And I'm pleased to report today that we have made significant progress with our internal, program. Indeed, in a short time period, we have achieved two essential properties, with potency at, nanomolar and sub-nanomolar levels and good metabolic stability, leading to highly promising compounds.
John Pierre Semidossi: We are now working to combine this potency and metabolic stability in a clinical candidate, which we hope to select later this year.
John Pierre Semidossi: Moving to slide 9, the antiviral effect of beniphosphazine, in combination with the protease, inhibitor Paxlovid, was examined in vitro in an HCALP2298-serogrid model. And the results indicate an additive antiviral effect.
<unk> therapy with <unk>.
John Pierre Semidossi: So not only we are encouraged by this data, but also this data supports the potential, benefit of a combination of beniphosphazine with a protease inhibitor for the treatment of COVID-19.
These programs are the <unk>.
Just to provide global solutions.
Okay, and you shouldn't shock going from severe retinal diseases and I look forward to reporting our progress in the months ahead.
With that operator, we will now turn 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 star one one on your telephone.
Wait for your name to be announced please standby, while we compile the Q&A roster.
Oh.
Our first question comes from the line of Tim Hugo Lugo.
From William Blair.
Your line is now open.
Thank you for taking my question and congrats on the progress in the quarter.
Just from a 10000 foot level it seems like <unk>.
While the bar below the regulatory shifts at the agency.
Maybe there are now more open to the monotherapy trial.
Yes.
And at the beginning of the year.
That wasn't the case can you talk about.
Is it just the updated Morningstar data, which.
And press them or is it.
I guess the issues with the Ti or is it all of the above.
Janet Hammond: I will turn the call over to Janet for a review of our dengue fever and hepatitis C programs.
Janet I would like to have those too.
Regression.
Thank you J P and thanks, Tim.
Janet Hammond: Janet?
Janet Hammond: Thank you, Jean-Pierre.
Janet Hammond: Turning to slide 11, I'll begin with a review of our program to treat dengue fever.
Janet Hammond: In recent weeks, hundreds of thousands of cases of dengue have been reported across, Southeast Asia, owing to the flooding and other climate-related issues experienced there. In the United States, in Miami-Dade County, a mosquito-borne illness advisory was issued, for dengue in late July after the first case was confirmed this year in a Florida resident.
Janet Hammond: We expect to report initial results from this study later in the year.
No I think to clarify.
Janet Hammond: There are no treatments for dengue. Dengue is the most prevalent mosquito-borne viral disease and affects almost 400 million, individuals on an annual basis. Dengue is endemic in over 100 countries, and more than half of the world's population is, at risk for it. There is a significant unmet medical need, and the global economic burden is estimated, to be between $8 billion to $9 billion annually.
Janet Hammond: We also initiated a second dengue study, which is a human challenge model in the United States. In this study, healthy volunteers are dosed with A3752 or placebo and then administered, a live dose of dengue virus. The subjects are closely monitored within a very controlled setting, allowing for the, assessment of viral load and the viral kinetics between the treatment groups.
Janet Hammond: As noted on slide 12, we continue to enroll patients in the DEFEND-2 trial, which is a, randomized phase 2 proof-of-concept study in patients with dengue fever. The study is designed to assess antiviral efficacy, safety, and the pharmacokinetics, of multiple doses of A3752 with a primary endpoint of change in dengue virus viral load from baseline. A3752 or placebo will be administered orally for five days in up to 60 patients with dengue, infection.
Janet Hammond: We also expect to report the preliminary results from this study later in the year.
Janet Hammond: Turning now to our Hepatitis C program.
We have not had discussions about combination therapy versus monotherapy with any agencies. So these were.
Janet Hammond: As shown on slide 14, our HCV combination development plan looks very promising, and, we believe that there is still room to improve upon the standard of care for hepatitis C. Our HCV combination profile includes convenient and short treatment duration, with the potential, for the first ribavirin-free therapy for decompensated disease.
End of phase II discussions that.
We reported now.
I don't believe there's any issue one way or the other.
With that.
Janet Hammond: We believe Ruzivir, in combination with Bemfostavir, provides the opportunity to create a best-in-class, pangenotypic HCV therapy.
I think they see a path forward for us.
Right.
A monotherapy and then potentially as combination therapy Olson.
Janet Hammond: We're continuing to make progress with our program and have completed a required combination, preclinical toxicology study.
Janet Hammond: We are currently manufacturing Ruzivir clinical trial supplies and are finalizing the phase, two clinical trial design.
Janet Hammond: We expect the phase two combination program to evaluate convenient and short treatment, durations in both non-sterotic and compensated patients with cirrhosis.
Janet Hammond: We anticipate initiating the study later this year.
Okay fair enough and is there any.
Andrea Corcoran: With that overview, I will now hand the call over to Andrea to review our financial information.
Can you just talk first thinking about using your own versus partnering with one of the other pis.
Obviously, there's parts of it but there are other kind of development stage candidates out there or something like that.
<unk> makes it is not quite right for combination.
Look.
We'll see.
The next six to 12 months.
As you know.
Uh huh.
The issues with respect to how is that going to remain whether monotherapy or combination and mostly as drug drug interaction and very likely we foresee that.
<unk>.
Combinations very likely when we are talking about specific population that we are talking about immuno compromised patients transplant.
You can have long term viral replication so.
Already you start with a major limitation, which is the drug drug interaction issues of poverty. So.
We have seen.
We're moving very fast.
With our second generation.
Our goal is.
Like we said.
A highly potent drug.
Rich.
Well.
Lead to low dose.
We foresee potential.
A.
Co formulation with <unk> caused severe let's not forget.
We have a low pill burden with plenty costs Ria has two pillars.
Twice a day, if you combine that with facts. So obviously, you're talking about five pills twice a day that quite a bit.
So we keep in mind all of this.
Yes.
We believe that we will as a best in class you will see that to my knowledge. This is the first time, we're reporting sub nine memorial concentrate.
On the mall.
And today, we start to see even.
Finding the Pica mall level, which this is what we would like to see as we are as we have in HIV HIV and HCV. So not to talk about it on the mall of Pica malls. So.
Let's see where we stand in the next.
Six to 12 months, but we believe that our combination corporate or a combination.
We will lead.
And how and create major benefits to patients.
Especially in those very high risk patients with COVID-19.
Andrea Corcoran: Thank you, Janet.
Alright, thank you for the color.
Andrea Corcoran: As Jonay mentioned in her introductory remarks, earlier today we issued a press release containing, our financial results for the second quarter of 2022.
Thank you Tim.
Andrea Corcoran: The statement of operations and balance sheet are on slides 16 and 17.
As a reminder, if you'd like to ask a question.
Andrea Corcoran: For the second quarter 2022, the decrease in R&D expenses in comparison to the second quarter of 2021 was driven principally by the discontinuation of our cost-share arrangement with Roche. This cost-share arrangement ceased when the collaboration with Roche ended earlier this year. The decrease was partially offset by an increase in R&D employee payroll and personnel-related expenses.
Andrea Corcoran: The nominal increase in G&A expenses in the second quarter 2022 over the second quarter 2021 was primarily due to an expansion of our organization and reflects an increase in payroll and personnel-related expenses.
Andrea Corcoran: We ended the quarter with a strong balance sheet, including cash resources in the amount of $684.5 million to support our clinical development programs. The cash expenditures during the quarter were $21.1 million.
Andrea Corcoran: We are reiterating our cash guidance with a runway through 2025.
Just need to dial star one on your telephone thank you.
John Pierre Semidossi: I'll now turn the call back over to Jean-Pierre for closing remarks.
Our next question comes from the line of Omar Ross <unk> from Evercore.
John Pierre Semidossi: Thank you, Andrea.
John Pierre Semidossi: Throughout the first half of 2022, we made considerable progress advancing our oral antiviral platform with the aim of transforming the treatment of severe viral diseases.
For AMR.
I would love to get a little bit more color.
About your expectations for the continuing market for Antivirals, I mean, obviously theres still unmet need in Covid.
John Pierre Semidossi: As the global demand for COVID-19 treatments continues and abated, we remain confident in the opportunity for Eteria to deliver a multi-pronged approach with best-in-class oral antivirals to treat COVID variants as the virus continues to evolve.
John Pierre Semidossi: On slide 19, as we look to the balance of the year, we expect to build on this momentum by achieving a number of value-creating milestones, including the initiation of our late-stage clinical trial of benifazivir for COVID-19, reporting preliminary clinical data from our dengue fever program, and the initiation of our phase 2 combination program in HCV.
John Pierre Semidossi: In addition, our goal is to select a second-generation protease inhibitor clinical candidate for COVID-19 combination therapy with benifazivir.
John Pierre Semidossi: These programs have the potential to provide global solutions for patients suffering from severe viral diseases, and I look forward to reporting our progress in the months ahead.
But by the time you.
Or either monotherapy or proposed combination is eligible for launching what do you think the ongoing COVID-19 market is going to look like at that stage.
Unknown Executive: With that, Operator, we will now open the call up to your questions.
Sure John do you want to address that question.
Unknown Executive: Thank you.
Yes, sure Jamie or yes.
I understand your question, we believe that the Covid.
19 index will really continue throughout the world right now recently, you've seen a multibillion dollar opportunity and Thats just for treatment there was no stockpiling there.
But even if you look at the current landscape that you have.
Which is the dominant player at least in the United States with tax loaded.
As J P said that due to the drug drug interactions with many commonly prescribed medicines.
That is not going to go away and these drugs are frequently used among those who are the most vulnerable.
The 19, and unfortunately is limiting the ability of <unk> to be prescribed.
Purely pre praising treatment dilemmas for both patients and prescribers.
And just to reiterate I think we always have seen that the commercial opportunity for COVID-19.
Really come from.
Two areas one will be for the active disease, such as what you see now and then once NDA approval comes.
That the government will stockpile that stockpiling will likely be similar to <unk>.
Other type numbers that we've seen before which is usually a percentage of the population that will be ongoing. So we don't see anything really changing at least on the current landscape that you see right now.
The liabilities of those assets, we see are continuing.
Unknown Executive: At this time, we'll conduct the question and answer session.
Okay, great that makes sense I guess.
One more.
And a positive.
Already discussed this but can you talk a little bit about viral rebound and whether the risk of that it would be different in combo in lung.
The rebound in the risk of say again please.
I'd love to talk a little bit about the expectations that other.
Antivirals have had with viral rebound and obviously, it's not just tax level you've seen similar reports from an interior, although it's not as widely used so I am wondering what you think about the risks there and whether combo will will meaningfully address that.
Well look we will have to.
To conduct this study.
To see if this benefit can be realized.
Uh huh.
We just see recent.
We recently.
Potential.
For a rebound.
Really not where they've been.
I would say.
Documented.
Just in this.
The review paper recently.
Perhaps swap it was clear.
And I think.
That it's really related to the mechanism of faction I want to talk about protease inhibitors, we are talking about the likely incomplete subtraction.
Incomplete.
Ah trial with application.
We'll get that back so all of those and also eight of one hour. So I mean that basically one.
The clearance occurred within one hour you're back on full viral application.
That's the major difference was with <unk>.
Nucleoside analogs, there whether you have changed feminism.
Irreversible process.
So.
Again.
We need first to have a good handle on real absolutely. There is several reports of talking about 2%, 5% 10%.
Uh huh.
Would be very <unk>.
Important to know exactly where we are talking some even mentioned 20 or 30% I would say very likely if varies.
Uh huh.
<unk>.
Different patient populations that are likely immuno suppressed.
<unk> towards a point when a compromise where youre potentially long term downward progression.
May occur at the highest rate.
And in combination.
We would expect.
Sure.
It led to those to those benefits, but obviously.
The studies will have to be to be conducted.
Alright. Thanks.
Yes.
Okay. Thank you.
Okay.
Our next call comes from the line of Nick ASIC with SBB Securities.
Hey, Good afternoon. Your line is now classic.
Hey, good afternoon, Mcgaffey gone for Rwanda relief. Thanks.
Thanks for taking our questions maybe first off on <unk> per year.
Lower hospitalization and gas is that right.
Impact our primary endpoint data for the less loss than the philosophy here.
Three.
Yeah.
Janet.
Sure.
I'm sorry, Nick I just want to thank you for your question Mike.
Mike hospitalization and death rates impact and with US today was that your question.
Hey, Janet I'm, just curious how might lower lower hospitalization and death event rates impact the primary endpoint data in phase III.
So I think I think obviously as an endpoint.
It may mean that we will need to explore more patients but.
I think one can also probably enrich for patient populations for these events are more likely to occur.
Once we have a final study design.
We're on our way.
Give you some idea of what we're anticipating to do but I think just a support level that could be.
We had to address that.
Got it that's very helpful and I think you previously mentioned.
Essentially optimizing five to seven the compound itself to get better exposures.
With a lower cost of goods curious if youre moving forward.
With those plans and with the optimized molecule.
Great.
Yes, basically we are moving forward with.
The.
New formulation.
Improve API the API.
And improve.
Production process to be able to synthesize multi tonne level.
Yeah.
And the formulation actually it's also a much more straightforward formulation process. So we actually just in the process to complete.
Phase one was this formulation.
So we will basically include the new CMC in the package for the quarter global trial as well.
Got it.
New compound won't be assessed in the phase III there'll be the prior 57 compound.
Correct exactly the same.
Got it and then lastly.
Potency data for <unk> figure I can speak for NPA five variance when do you expect to share this data and how do you expect then this last years.
Tony the holdup, I guess future variance.
Sure look.
You have seen in the slide.
Yes.
Regardless of the vein and we search major differences.
And.
The sequence, especially when we compare to your own microns, whereas the outside the better of the Delta.
There is no difference at all not surprising.
I'm in a preliminary these highly conserved I'd like to remind you that.
Any sort of variance.
Exactly 100% homology India.
Putting noise sequence.
And the only difference.
And in the Spike protein so.
It's going to take a couple of months.
Again to deal with.
Especially to be a five.
We have activity against BK, one SBA too I would say that.
I can tell you already have the data that we're going to be a fact.
And when do we see the future.
Again.
It's important to note that we have not seen any significant.
A mutation in the <unk>.
According to <unk> the only one.
As compared to the original Wuhan.
Our strength is the street 23 mutation, which is the interface between the land and the <unk> and actually we have reported that.
And one of our clinical trials, we have 98% of these patients add mutations so.
This is why.
The.
Nucleoside.
Analog.
I like to make a difference with specifically projecting the island and accordingly lies with a chain termination.
<unk> mechanism.
We don't anticipate that any.
Any different regardless of.
The future of that.
Got it that's helpful. And then lastly on 75 two in dengue.
Maybe I am just curious what are you hoping to see in the phase II data set in terms of efficacy.
And are there any particular.
Particular safety signals you are watching closely.
Janet.
Just a question.
So we're looking.
In the treatment trial, we're looking primarily to see declining inbound.
And this happens naturally fairly quickly, but we believe that.
Without within with clinical effect, you should see a more rapid and more deep.
Scrapping violate.
And so that would be the primary endpoint will also be looking at symptoms.
We have a fair amount of experiencing a phase one trials with regards to.
Constant in its profile is actually being well tolerated unsafe and so we will obviously be monitoring for that one also looking at the pharmacokinetics.
The viral kinetics, how ready the primary endpoint.
Aspect of that comes into evaluation also.
We are going to potentially have a couple of different doses and dosing regimens.
Pending on how we get from cohort to cohort.
I mean, there is the biggest thing that's what they're looking for.
Got it Super helpful. Thank you gentlemen, I'll hop back in the queue.
Thank you Nick.
Unknown Executive: As a reminder, to ask a question, you'll need to press star 11 on your telephone and wait for your name to be announced.
If there's anyone else who has a question. Please press Star Star Star one on your telephone will be put in the queue.
Unknown Executive: Please stand by while we compile the Q&A roster.
Unknown Executive: Our first question comes from the line of Tim Lugo from William Baer-Sawyer.
If there are no further questions at this time I'd like to hand, it back to John <unk> for closing remarks.
Unknown Executive: Your line is now open.
Okay.
Timothy Lugo: Thank you for taking the question and congrats on the progress in the quarter.
Timothy Lugo: I guess from a 10,000 foot level, it seems like there might have been a bit of a regulatory, shift at the agency where, you know, maybe they're now more open to the monotherapy trial, whereas, you know, maybe at the beginning of the year, that wasn't the case.
Thanks Peter.
John Pierre Semidossi: Can you talk about, is it just the updated MorningSky data, which, you know, impressed, them, or is it just, I guess, the issues with the PI, or is it all of the above?
Janet Hammond: Janet, would you like to address the question?
Uh huh.
Thank you again for joining us today.
Look forward to report.
More progress in the fall thank you.
Janet Hammond: Thank you.
Unknown Executive: Thank you everyone for your participation in today's conference.
Janet Hammond: Yes, JP.
Unknown Executive: This concludes the program and you may now disconnect.
Janet Hammond: Thanks, Tim.
Janet Hammond: No, I think to clarify, we have not had discussions about combination therapy versus monotherapy, with any agencies.
Janet Hammond: So, these were interface to discussions that we reported now.
Thank you everyone for your participation in today's conference. This concludes the program and you may now disconnect.
Janet Hammond: And so, I don't believe there was any issue one way or the other with that.
Janet Hammond: And I think they see a path forward for us, you know, both as monotherapy and then potentially, as combination therapy also.
Unknown Attendee: Okay.
Unknown Attendee: Fair enough.
Unknown Attendee: And is there any, can you just talk about thinking about using your own PI versus partnering, with one of the other PIs?
Unknown Attendee: Obviously, there's PaxLavid, but there are other kind of development stage candidates, out there.
Unknown Attendee: Is there something that just makes those not quite right for combination?
Unknown Attendee: Look, we'll see, you know, in the next 6 to 12 months.
Unknown Attendee: As you know, the issues with PaxLavid are going to remain whether monotherapy or combination, and mostly it's drug-drug interaction.
Okay.
Unknown Attendee: And very likely, we foresee that the combinations are very likely when we are talking about, specific population, we are talking about immunocompromised patient transplant, where you can have long-term viral replication.
Unknown Attendee: So already, you start with a major limitation, which is the drug-drug interaction issues, of PaxLavid.
Okay.
Unknown Attendee: So as you have seen, we are moving very fast with our second generation.
Unknown Attendee: Our goal is to have, like we said, a highly potent drug, which will lead to low dose.
Unknown Attendee: We foresee potential a co-formulation with Benifazlavir.
Unknown Attendee: Let's not forget, we have a low pill burden with Benifazlavir, it's 2 pills twice a day.
Unknown Attendee: If you combine with PaxLavid, you're talking about 5 pills twice a day, that's quite a, bit.
Unknown Attendee: So we keep in mind all this.
The conference will begin shortly to raise your hand during Q&A you can dial star one one.
Unknown Attendee: But we believe that we will have a best in class.
Unknown Attendee: You see that, to my knowledge, this is the first time we're putting sub-nanomolar potency.
Unknown Attendee: We start to see even binding at the picomole level, which this is what we would like to, see as we are in HIV and HCV. So not to talk about nanomoles, but picomoles.
Unknown Attendee: So let's see where we stand in the next 6 to 12 months.
Unknown Attendee: We believe that our combination, proprietary combination, will lead and help and create, major benefits for patients, especially in those very high risk patients with COVID-19.
Unknown Attendee: Thank you for calling.
Unknown Attendee: Thank you, Tim.
Unknown Executive: As a reminder, if you'd like to ask a question, you'll just need to dial star 11 on your telephone.
[music].
Unknown Executive: Thank you.
Unknown Executive: Our next question comes from the line of Umar Rafat from Evercore.
Unknown Executive: For Umar, I would love to get a little bit more color about your expectations for the continuing market for antivirals.
Unknown Executive: I mean, obviously, there's still unmet need in COVID, but by the time your either monotherapy or proposed combination is eligible for launching, what do you think the ongoing COVID market is going to look like at that stage?
Unknown Executive: Sure.
Unknown Executive: John, do you want to address that question?
Okay.
Unknown Executive: Yes, sure.
[music].
Unknown Executive: Umar, yes, I understand your question.
Unknown Executive: We believe that the COVID-19 endemic will really continue throughout the world. And right now, recently, you've seen the multibillion dollar opportunity, and that's just for treatment.
Unknown Executive: There's no mention of even stockpiling there.
Unknown Executive: But even if you look at the current landscape that you have, which the dominant player, at least in the United States, is Paxlovid, you know, as JP said, that due to the drug-drug interactions with many commonly prescribed medicines, that is not going to go away.
Unknown Executive: And these drugs are frequently used among those who are the most vulnerable to COVID-19.
Unknown Executive: And unfortunately, it's limiting the ability of Paxlovid to be prescribed, and really praising treatment dilemmas for both patient and prescribers.
Unknown Executive: And just to reiterate, I think we always have seen that the commercial opportunity for COVID will really come from two areas.
Unknown Executive: One will be from the active disease, which is what you see now.
Unknown Executive: And then once NDA approval comes, that the government will stockpile that.
Unknown Executive: And the stockpiling will likely be similar to other types of endemics that we've seen before, which was usually a percentage of the population that will be ongoing.
Unknown Executive: So we don't see anything really changing, at least on the current landscape that you see right now.
Unknown Executive: The liabilities of the disasters we see are continuing.
Unknown Executive: Okay, great.
Unknown Executive: That makes sense.
Unknown Executive: I guess one more, and apologies if we already discussed this, but can you talk a little bit about viral rebound and whether the risk of that is going to be different in combo and mono?
Unknown Executive: Viral rebound and the risk of SAGF, please?
Unknown Executive: I'd love to talk a little bit about the expectations that other antivirals have had with viral rebound.
Unknown Executive: And obviously, it's not just Paxlovid.
Unknown Executive: You've seen similar reports from molnupiravir, although it's not as widely used.
Unknown Executive: So I'm wondering what you think about the risks there and whether combo will meaningfully address that.
Unknown Executive: Well, look, we will have to conduct a study to see if this benefit can be realized, right?
Unknown Executive: We just see recently potential for a rebound of molnupiravir, although it has really not been, I would say, documented just in this review paper recently.
Unknown Executive: Paxlovid is clear. And I think that it's really related to the mechanism of action. When we talk about protease inhibitors, we are talking about the likely incomplete suppression, incomplete viral replication.
Unknown Executive: Let's not forget that Paxlovid has an off-rate of one hour.
Unknown Executive: That means that basically when the clearance occurs within one hour, you're back on full viral replication.
Unknown Executive: That's the major difference with nucleoside analog, where you have chain termination.
Unknown Executive: You have an irreversible process.
Unknown Executive: So, again, we need first to have a good hand on relapse.
Unknown Executive: There are several reports that talk about 2 percent, 5 percent, 10 percent.
Unknown Executive: It would be very important to know exactly where we are talking.
Yes.
Unknown Executive: Some even mention 20 or 30 percent.
[music].
Unknown Executive: It varies among different patient populations. Very likely immunosuppressed patients, for example, immunocompromised, where you have potentially long-term viral replication, may occur at the highest rate.
Unknown Executive: And combination, you will expect, should lead to those benefits.
Unknown Executive: But obviously, the studies will have to be conducted.
Unknown Executive: Thank you.
Unknown Executive: Our next call comes from the line of Nick Gasek with SVB Securities.
Unknown Executive: Hey, good afternoon.
Unknown Executive: This is Nick Gasek on for Rwanda Relief.
Unknown Executive: Thanks for taking our questions.
Unknown Executive: Maybe first off on BEMNIFOSPIVIR, how might lower hospitalization and death event rates, impact primary endpoint data for BEMNIFOSPIVIR in Phase 3?
Unknown Executive: Janet?
Unknown Executive: I'm sorry, Nick.
Unknown Executive: I didn't completely hear your question.
Unknown Executive: How might hospitalization, and death rates impact BEMNIFOSPIVIR?
Unknown Executive: Was that your question?
Unknown Executive: Hey, Janet.
Unknown Executive: Yeah, I'm just curious.
Unknown Executive: How might lower hospitalization and death event rates, impact the primary endpoint data in Phase 3?
Unknown Executive: So, I think, obviously, as an endpoint, it may mean that we will need to explore more patients, but I think one can also probably enrich for patient populations where these events are more likely to occur.
Unknown Executive: So, once we have a final study design and we're on our way, we'll give you some idea of what we're anticipating to do.
Unknown Executive: But I think just at a board level, that would be how we have to address that.
Unknown Executive: Got it.
Unknown Executive: That's very helpful.
Unknown Executive: And I think you previously mentioned potentially optimizing 527, the compound itself, to get better exposures with a lower cost of goods.
Unknown Executive: Curious if you're moving forward with those plans and with the optimized molecule in Phase 3. Yeah, basically, we are moving forward with the new formulation and improved API. The API is just, an improved production process to be able to synthesize multi-ton level. And the formulation, is also a much more straightforward formulation process.
Unknown Executive: So, we are actually just in the process to complete Phase 1 with this formulation.
Unknown Executive: So, we will basically include the new CMC in the package for the global trial as well. Got it.
Unknown Executive: So, this new compound won't be assessed in the Phase 3.
Unknown Executive: It'll still be the prior 527 compound. Correct.
Unknown Executive: Exactly the same.
Unknown Executive: Got it.
Unknown Executive: And then lastly, on potency data for Benda-Fosbuter against BA4 and BA5 variants, when do you expect to share this data?
Unknown Executive: And how do you expect Benda-Fosbuter's durability to hold up against future variants of concern?
Unknown Executive: Look, as you have seen in the slide, regardless of the variant and with such major differences in the sequence, especially when we compare the O-micron with the alpha, the beta, the delta, there is no difference at all. Not surprising as the RNA polymerase is already conserved.
Unknown Executive: I'd like to remind you that, any surveillance of exactly 100% homology in the RNA polymerase sequence, and only you have a difference in the spike protein.
Unknown Executive: So, you know, it's going to take a couple of months again to develop, especially the BA5, you know, We have activity against BA1, now against BA2.
Unknown Executive: I think that I can tell you already the data that we are going to get with BA5.
Unknown Executive: And when we see the future, again, it's important to know that, we have not seen any significant mutation in the RNA polymerase.
Unknown Executive: The only one, as compared to the original Wuhan strain, is the 323 mutation, which is at the interface between the NIRAN and the polymerase.
Unknown Executive: And actually, we have reported that in one of our clinical trials, we had 98% of these patients add that mutation.
Unknown Executive: So, you know, this is why the nucleoside analog, especially, and I like to make a difference with specifically targeting the RNA polymerase with a chain termination mechanism.
Unknown Executive: We don't anticipate that you're going to see any difference, regardless of the future variant.
Unknown Executive: All right.
Unknown Executive: That's helpful.
Unknown Executive: And then lastly, on 752 in dengue, maybe I'm just curious, what are you hoping to see in the phase 2 data set in terms of efficacy?
Unknown Executive: And are there any particular safety signals you're watching for closely?
Unknown Executive: Janet, would you like to address the question?
Unknown Executive: So we're looking in the treatment trial, we're looking primarily to see a decline in viral load. This happens naturally fairly quickly, but we believe that with clinical effects, you should see a more rapid and more deep drop in viral load.
Unknown Executive: And so that would be the primary endpoint.
Unknown Executive: We'll also be looking at symptoms.
Unknown Executive: We have a fair amount of experience in our phase 1 trials with the drugs, so we are confident in its profile as actually being well tolerated and safe. And so we will obviously be monitoring for that and also looking at the pharmacokinetics.
Unknown Executive: But the viral kinetics are really the primary endpoint and the main aspect that we're attempting to evaluate.
Unknown Executive: And also, we're going to look potentially at a couple of different doses and dosing regimens, depending on how we go from cohort to cohort.
Unknown Executive: But those will be the things that we'll be looking for.
Unknown Executive: Got it.
Unknown Executive: Super helpful.
Unknown Executive: Thank you, Janet.
Unknown Executive: I'll hop back in the queue.
Unknown Executive: Thank you, Nick.
Unknown Executive: If there's anyone else who has a question, please press star, star, star, one, one on your telephone.
Unknown Executive: You'll be put in the queue.
Unknown Executive: If there are no further questions at this time, I'd like to hand it back to Jean-Pierre for closing remarks.
John Pierre Semidossi: Thank you.
John Pierre Semidossi: Thank you again for joining us today and look forward to report more progress in the fall.
Unknown Executive: Thank you.