Q1 2024 Atea Pharmaceuticals Inc Earnings Call
Okay.
Good afternoon, everyone and welcome to the NCI Pharmaceuticals first quarter 2024 financial results and business update conference call at.
At this time all participants are in a listen only mode.
The formal remarks, we will open the call up for your questions I would now like to turn the call over to Jay Barnes.
Vice President of Investor Relations and corporate communications.
Jonae R. Barnes: Besides please proceed.
Thank you and good afternoon, everyone and welcome to a care Pharmaceuticals first quarter 2024 financial results and business update conference call earlier today, we issued a press release, which outlines the topics. We plan to discuss you can access the press release as well as the slides, we'll be reviewing today by going to the investors section of our web.
Site at IR dot it pay a form of dot com with me today from our Chief Executive Officer, and founder Dr. John P or somebody does see doctor around sort of workout Chief Medical Officer, Chief Development Officer Dr.
Chief Financial Officer, and Executive Vice President legal.
And 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 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 comps.
<unk> 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 Sean here.
Thank you John and good afternoon, everyone and thank you for joining us.
24 is off to a strong start with the tremendous clinical progress we have made across all programs with COVID-19 and HCV.
Can see on slide three.
I will begin first with an overview of our Benny fast moving program for the treatment of COVID-19.
Trends observed in 2024 provides further evidence that coverage is endemic and easier to start.
Jonae R. Barnes: And it's continued to evolve and this winter we experienced a surge of infections caused by the very on Jan one.
Jonae R. Barnes: Our strong operational execution led to the rapid and successful enrollment of the Orly Global Phase III trial exclusively conducted in the high risk patients.
As a final guidance.
We randomized 2200 21 patients.
Into the supported Cameron a therapy called and only 74 patients into the combination therapy cool with 77% of total patients enrolled in the <unk>.
Nike stays.
Strikingly the clear preference by the investigators to enroll high risk patients in the monotherapy cohort.
The continuing unmet medical need for new all COVID-19 treatment options for these high risk patients.
We believe that any philosophy has the potential to address many of the key limitations of current COVID-19 therapies, including safety.
Liability and drug drug interaction.
We look forward to potentially delivering benny possibly up to millions of patients for whom the current standard of care is not an optimum auction.
Anticipate topline results from Sunrise III in the second half of 2024.
Turning now to our phase II program for Hepatitis C.
Building off the positive 98%.
As we are for right from the lithium cohort of 60 patients. We look forward to multiple key near term milestones towards this program.
We are very excited about the upcoming presentation at <unk> next month, which will showcase preclinical and new phase II efficacy data from this lithium cobalt.
We also look forward to reporting complete SBR trough results from this ongoing study during the second half of 'twenty 'twenty. Four. In addition, we are preparing for the initiation of a phase III study, which we anticipate around the end of this year. We are currently.
Analyzing the selection of the fixed dose combination tablets, which would be used in the phase III program as well as for commercialization.
<unk> is the most potent nucleoside inhibitor for hepatitis C treatment and the rest is where he is a highly potent and that's five inhibitor. We believe that the demonstrated synergistic effect of this combination can substantially improve upon the current standard of care for all.
In fact, with hepatitis C and clothing.
Those who are the hardest to treat and then ran so where do we view our HCV program in.
In greater detail next importantly, we are in a strong financial position to execute our strategy with five and at the end.
$41 five millions of cash cash equivalents and marketable securities at March 31st with a runaway now anticipated into 'twenty 'twenty. Seven this is based on completing patient enrollment for Sunrise. We are ahead of schedule.
And our ongoing financial discipline.
Andrea: Andrea will provide a detailed update on <unk> financial position during today's call with that I will now turn the call over to a rent central and update on our global Phase III HCV program.
Thank you Cynthia.
Turning to slide five.
Andrea: Despite the availability of treatment options HCV continues to be a health care crisis in the U S HCV survival disease with unmet medical needs.
Cynthia: The need for a shorter treatment duration fewer country indications and less potential for drug drug interactions.
Cynthia: New and re infection rates.
Speaker Change: <unk> exceed the cure rates in the U S. What are their 2 million individuals are estimated to be infected.
unknown: Moving to slide six we believe that the combination of many Clos will be down versus beer has the potential to be a best in class treatment regimen by being cut days can you beat the free with a short eight week treatment duration.
Speaker Change: It also has a low risk of drug drug interactions and there is no food effect.
Kols: The properties are in market research, we have conducted on Kols feedback to date supports our high confidence in this combination therapy, which has the potential to address these remaining unmet needs.
Kols: Turning to slide seven.
Kols: HCP market demand grew roughly 5% in 2023.
Kols: Just on the number of patients treated with a market share of the two key HCV treatment options at close hand love It remaining stable.
Kols: With an estimated 2 million plus people in the U S living with chronic HCV. There is a large number of patients to be treated the patient pool continues to be replenished with approximately 100000, new chronic cases, each year, we believe that the best in class profile of any portfolio on root cause there.
Kols: Together with the anticipated teach her government initiatives and removal of access barriers, including certain constraints by Payors will increase the number of patients care for these severe viral disease.
Kols: Slide eight outlines our phase two single arm open label study of 550 milligrams have any cost will be in combination with 180 milligrams of looses there once daily for eight weeks.
Speaker Change: We plan to enroll up to 280 treatment naive patients across all genotypes, including the leading cohort of 60 patients.
Speaker Change: So in the initial 60 patient cohort.
Speaker Change: <unk> biological response or SBR at week four post treatment.
Speaker Change: Youth is the decision criteria to continue enrollment to complete the phase two study.
A reminder: A reminder, the primary endpoint of the study is M. P. At week 12 post treatment I'm safety.
Speaker Change: Slide nine.
Speaker Change: Before we review the slide I want to provide a brief background on the based on demographics and baseline characteristics in the leading cohort of 60 patients.
Speaker Change: Comprised of non cirrhotic patients only however, 10 patients had an advanced stage of fibrosis S. Three which is borderline with cirrhosis.
Speaker Change: This final results from the leading cohort with 98% that would be a home run.
Speaker Change: Treatment across all genotypes involved.
Speaker Change: Slide 10.
Jos: Jos the on treatment viral kinetics of individual patient data from the leading cohort.
Jos: By week four on treatment all 60 patients in the leading cohort had viral load near or below.
Jos: Lower limit of quantification. Therefore, this very rapid kinetics across all genotype support an eight week regimen and compare favorably to love It which is the only approved eight week treatment part of Chile.
Speaker Change: I turning to slide 11, the combination of many thoughtful leader who spoke to here was generally safe and well tolerated in the leading cohort.
Speaker Change: No drug related serious adverse events, no discontinuation and adverse events were mostly mild.
Speaker Change: Moving to slide 12.
Speaker Change: To summarize our HCV SVR supported by positive, leaving cohort data, we initiated patient enrollment in January for the remainder of the phase two trial, we expect to enroll up to a total of 280 patients at 50 clinical sites across 15.
unknown: All countries, including the U S.
Speaker Change: Looking ahead.
Speaker Change: We are very excited about upcoming data presentations at <unk>, including the new phase two efficacy data from the leading cohort we expect to report complete phase two as we have 12 results in the second half of this year.
Speaker Change: Additionally over the first half of 'twenty 'twenty four we're conducting phase one studies in the U S for the selection of the best fixed dose combination tablet, which will be evaluated in the phase III program and used for subsequent commercialization, we anticipate that the phase III program will be.
Speaker Change: <unk> initiated around the end of this year.
Speaker Change: Slide 13 next I'll turn the call over to Janet to provide an update on our coffee program.
Janet: Good afternoon, everyone Slide 14.
Janet: Your reiteration.
Janet: Our remarks, COVID-19 continues to be an established pathogen is concerned with significant unmet need despite the availability of approved vaccines and antiviral treatment option.
Janet: Novartis continues to quickly evolve.
Janet: The recent filing of Orange nicknamed flat after that mutations in K P. Two which is now the dominant glaring ever taking Jay and one in the United States.
Novartis: I'll go for cases is to deliver a safe and effective treatment for the millions of patients for whom the current standard of care is notional more option.
Speaker Change: Any foster that has a robust target product profile with a nervous cause drug drug interactions.
Speaker Change: <unk> safety and Tolerability.
Speaker Change: Distinct mechanism of action with a high barrier to resistance.
Speaker Change: In a therapeutic area with a $4 billion plus market opportunity and Andy to antiviral product approved we believe there are any cost of its compelling clinical profile and overall value proposition presents a strong opportunity for potential market expansion the uptick.
Speaker Change: Moving to slide 15.
Speaker Change: In the first quarter, which included enrollment in Sunrise screen.
Speaker Change: Global Phase III trial, evaluating Benny Foster therefore, COVID-19 in high risk patients.
Speaker Change: Some nice tree is turnkey the urgent phase III program exclusively in high risk patients with hospitalization, rather than sinton alleviation as the primary endpoint through day 29.
Benny Foster: The secondary endpoints measured patient outcomes through day 60 post treatment.
Benny Foster: I am pleased to report the patients enrollment finished ahead of all guy.
Speaker Change: This is a significant achievement and demonstrates a strong operational execution and preparation to be ready to capitalize on the Jan one there and such.
Speaker Change: We enrolled 2221 patients in the monotherapy cohort and early 74 patients in the combination canceled.
Speaker Change: We were surprised to see such a high rate of enrollment in the monotherapy cohort.
Speaker Change: The care preference.
Speaker Change: This is to enroll patients in the monotherapy careful highlights the major unmet medical need for new are all COVID-19 treatment options for these high risk patients.
Speaker Change: In particular, we experienced strong enrollment in the U S with sites, who are responsible for 77% of all the patients enrolled.
Speaker Change: Turning to slide 16.
Speaker Change: I will now review, our Sunrise III global Phase III trial.
Speaker Change: This trial enrolled high risk patients with mild to moderate COVID-19, regardless of vaccination schedule.
Speaker Change: <unk> five or less days before randomization.
Speaker Change: As a reminder, this phase III trial was randomized double blind and placebo controlled the study drug.
Investigator: But then you talked about 550 milligrams B I D or placebo was administered concurrently with the newly available standard of care, including other compatible COVID-19 drugs at the discretion of the investigator.
Investigator: The primary endpoint for the study is all cause hospitalization or death.
Speaker Change: <unk> 29 in the supportive care monotherapy population.
Speaker Change: The secondary endpoints are COVID-19 related hospitalizations and death.
Speaker Change: Medicare tender visits.
Speaker Change: Symptom relapse through day 60, Chris treatment.
Chris: With a fast track designation.
Chris: And supportive data presented an estimate and stronger than expected enrollment trends specifically as seen in the monotherapy cohort. We're pleased with the execution and look forward to providing the results from our phase III trial during the second half of 'twenty 'twenty four.
John Boyle: Slide 17, I will now hand, the call to John to discuss the market opportunity for COVID-19.
John Boyle: Thanks, Janet turning to slide 18, the U S prescription demand for oral anti virals to treat COVID-19 highly correlates with infection rates, we believe the market opportunity for oral antiviral therapeutics for COVID-19, we will continue to remain a multibillion dollar opportunity for the <unk>.
Janet: Long run.
Janet: This is supported by acuity as retail prescription data, indicating between four and $5 billion.
John Boyle: Annual revenues between the only two approved oral antiviral products.
Janet: A significant unmet need still exist with limitations due to drug drug interactions and tolerability with Pac fluid and safety concerns with like embryo we.
John Boyle: We believe in <unk> severe and its potential to greatly improve the treatment landscape and bring meaningful value to patients and physicians I will now turn the call over to Andre to discuss.
John Boyle: Financials.
Andre: Thank you John.
Andre: Your name mentioned in her introductory remarks earlier today, we issued a press release containing our financial results for the first quarter 2024.
Andre: Shipment of operations and balance sheet are found on slides 20 and 21.
Andre: There was a market increase in research and development expenses for the first quarter 2024 compared to the corresponding period in 2023.
Speaker Change: This increase was primarily driven by higher external spend related to the completion of enrollment of our Sunrise III clinical trial and advancement of our HDD phase two clinical trial.
Andre: G&A expenses remained relatively consistent for the first quarter 2024 compared to the first quarter 2023.
Andre: Interest income also remained relatively consistent to the first quarter 2024 compared to the corresponding in 2023 due to investing in higher yield marketable securities and higher interest rates.
Andre: During 2024, we anticipate our quarter over quarter R&D spend to vary as we complete sunrise three and our HCC phase two study and then engage in activities to initiate the HCP phase III program in the fourth quarter of this year.
Speaker Change: At the end of the first quarter of 2024, our cash cash equivalent and marketable securities balance was $541 $5 million with patient enrollment completed this hub schedule for Sunrise III and our ongoing financial discipline, we now project, our cash guidance from <unk> into 'twenty.
Andre: 27.
Speaker Change: I'll now hand, the call back to <unk> for closing remarks. Thank.
Andrea: Thank you Andrea.
Andrea: We have made meaningful progress in the first quarter as a result of strong execution across both program for COVID-19 in HCV.
Andrea: Our current momentum position of set there for an exciting year ahead.
Andrea: Indeed, we have multiple key milestones for both program expected this year, which have the potential to drive significant shareholder value for COVID-19. They include the topline results from Sunrise III in the second half of 2024.
Speaker Change: Target submission expected around year end.
Speaker Change: These milestones followed recent SaaS and unexpected enrollment of almost 2300 pesos.
Speaker Change: Global Phase III study exclusively in the high risk patients.
Speaker Change: Janet has reminded us a.
Speaker Change: Sparks.
Janet: Our multi pronged approach against COVID-19, we continue to also make progress with our discovery program focused on the highly differentiated second generation protease inhibitor <unk> and we expect to provide an update on this program later this year.
Janet: HCV in the first quarter.
Janet M. J. Hammond: Based on the positive and 98% SVR for results in the lithium cohort of 60 patients. We are now completing enrollment for up to 220 additional patients in the ongoing phase II study.
Janet: Okay.
I mentioned: As I mentioned, we are extremely excited to show cause to showcase great clinical and new phase III efficacy results in support of our HCV program of diesel.
Janet: June.
Janet: Next months.
Janet: Looking ahead to.
Speaker Change: Complete SVR 12 results all patients enroll in the phase III study are anticipated in the second half of 2024, and we are optimistic that this was.
Speaker Change: When we flip the strong SVR for efficacy.
Speaker Change: Efficacy data that we have reported.
Speaker Change: We are targeting phase III program initiation.
Speaker Change: Around the end of this year.
DSA: I'm always impressed with DSA a team effort considering that we are a company with less than 80 employees successfully carrying out to global studies in diseases with multi billion dollar market opportunity with great efficiency and financial discipline.
DSA: <unk> shared with us.
DSA: We believe that our product candidates.
DSA: Highly differentiated and they have the opportunity if approved to fill a significant unmet medical needs in the current treatment landscape with strong blockbuster potential.
Operator: That I would turn the call back over to the operator.
Operator: Thank you.
Operator: Ask a question you will need to press star one on your telephone to withdraw your question. Please press star one again, please wait for your name to be announced please standby, while we compile the Q&A roster.
Speaker Change: One moment for your first question. Please.
Operator: Our first question comes from the line of Eric Joseph with Jpmorgan. Your line is now open.
Eric William Joseph: Hi, there it's purely on for Eric Thanks for taking our question.
Eric William Joseph: I know before you've mentioned about how.
Eric William Joseph: Any HIV HCV trials <unk> been rolling Cirrhotic patients I was just wondering kind of on a percentage basis, how sizable that it would be.
Eric William Joseph: The 220 patients.
Eric William Joseph: Alright.
Speaker Change: Can you answer the question please.
Eric William Joseph: Yes.
Eric William Joseph: Well.
Speaker Change: It depends on how many we enroll we have targets in the protocol and our target would be to enroll at least 10% between 10 and 20%.
Speaker Change: And it is our target.
Speaker Change: We listen.
Speaker Change: Alright, Thank you and then kind of.
Speaker Change: Looking at the further ahead with the HBV trial.
Speaker Change: What exactly how would you describe the pathway for registration for this and.
Speaker Change: Is this something you would look potentially to do yourselves all look for a partner to <unk>.
Speaker Change: <unk>.
Speaker Change: Okay.
Speaker Change: As you would anticipate we will have to.
Speaker Change: End of Phase II meeting.
regulators: With the regulators.
regulators: We anticipate that we will need two trial two phase III trials.
regulators: Dissipated that one of the two very likely would be against a comparator.
regulators: We anticipated that.
Speaker Change: The trial.
regulators: B.
B: Uh huh.
Speaker Change: Including H C H CV HIV co infected patients likely.
Speaker Change: Because of the drug drug interaction with <unk>, we are anticipating that the regulators will.
Speaker Change: I agree with us that he will be a head to head against him closer, but obviously I cannot speak for the regulators.
B: And.
B: <unk>.
Speaker Change: And we anticipate this year.
regulators: Andrea.
Andrea: We have a very strong balance sheets.
Andrea: And.
Andrea: For the phase III clinical program.
regulators: <unk>.
Speaker Change: <unk> being a strong position to execute our self of the phase III program.
Speaker Change: And we have already.
Speaker Change: Operations.
Speaker Change: In many countries in terms of regulatory approval for the phase III.
Speaker Change: Rich.
Rich: Good said to move into the phase III program, including the United States. So we anticipate that we will do ourself.
Speaker Change: Phase III program.
Speaker Change: Thanks for taking our questions.
Operator: Thank you one moment for our next question. Please.
Speaker Change: Our next question comes from the line of Matt Maxwell score with Morgan Stanley. Your line is now open.
Speaker Change: Great. Thank you I was wondering if you would provide any thoughts on shionogi is recent phase III update which they miss on the primary.
Speaker Change: And their intention to meet with the FDA also which secondary endpoints in the Sunrise <unk> III trial would you call out as particularly important given the competitive landscape. Thank you very much.
Speaker Change: Thank you Max.
Speaker Change: Janet.
Janet M. J. Hammond: Thank you, yes, so with regard to those shionogi phase III trial, I think our inflammation is much the same as yours I think.
Janet M. J. Hammond: To some extent.
Janet M. J. Hammond: Symptom endpoint has been a case, which has not been successful for companies developing antiviral drugs in the space and so I think.
Speaker Change: Some of the things which are different from that trial.
Speaker Change: We're really I think first and foremost.
Speaker Change: They selected to go after this as the primary endpoint I think they were pains to point out that they did succeed on a subset of their symptoms. However.
Speaker Change: However.
Speaker Change: Its obviously disappointing season sailing.
Speaker Change: On that key primary endpoint.
Speaker Change: We.
Speaker Change: I've mentioned.
Speaker Change: Single hospitalization, because we have.
Scot: The strong proof of principle on that Tomorrow morning, Scot study and our population is different from that and that we enrolled exclusively high risk patients worth of utilization continues to be a problem.
Speaker Change: However, I think that obviously hospitalization hasnt been.
Speaker Change: As common as it was previously which is also good.
Speaker Change: So.
Speaker Change: I think in regards to secondary endpoints, we have endpoints, which are comparable to what others have in terms of looking.
Speaker Change: For <unk>.
Speaker Change: Reductions in viral allergic patients looking also for substantial evidence of.
Speaker Change: Viral rebound this is something which is being described I think 13 placebo treated patients and we have a commitment to look at that also looking for evidence of emergence of resistance.
Speaker Change: And also looking for.
Jim: Hospitalizations and Medicare tend to visit all the way through day 60. So I think those are the key endpoints that right Jim.
Jim: Great. Thank you.
Speaker Change: Thank you one moment for our next question. Please.
Omar <unk>: Our next question comes from the line of Omar <unk> with Evercore ISI. Your line is now open.
Omar <unk>: Hi, guys. This is Jon on for Omar.
Speaker Change #108: I would like to start with.
Jon: The expectation that you do two phase III is internally. So does your current run rate guidance to 2007 include two phase III for HCV.
Omar <unk>: And then.
Omar <unk>: Secondly.
Jon: Obviously, you need to have that meeting with the FDA, but do you have a sense of what the timeline for the Registrational program could be.
Speaker Change #100: Your assumptions about trial design are all true how long do you think those trials would take two to run and then just lastly on the easel data coming up later this month.
Speaker Change #103: We are going to include new data on the lead in cohort is that going to include long term SVR of I guess, you are 12 for that lead in cohort or just fuller details invest carefully.
Speaker Change #103: Thank you John.
Speaker Change #102: Just to address your second part of the question.
Speaker Change #105: We're presenting new phase II efficacy data.
Speaker Change #107: As you know the embargo for abstracts lift from May 22nd and we would be excited to presented data on June 1st.
Speaker Change #111: We cannot say more than that not to break.
Speaker Change #113: The embargo on the on diesel.
Andreas: Andreas can you.
Speaker Change #100: Great.
Speaker Change #109: The final straw.
Speaker Change #100: The budget in terms of what three includes onto go all the way through 2027.
Speaker Change #106: Although the regulatory part.
John: Yes, yes, John So in answer to your question our guidance does anticipate that we will have Tuesdays III trials and they will be completed.
Speaker Change #117: During that window of time with our existing resources.
John: And regarding timelines.
John: This completes at.
John: At the end of the phase two and the agreement with the regulators.
John Boyle: Obviously first in the U S and in Europe, but it definitely would be global trials. So we have to deal with federal regulators.
Speaker Change #110: So I think we will have a better view.
John: In 2025 and share what we see as timelines John.
John: Makes sense just one final one I guess on Sunrise youre guiding to data in second half, but fair to assume that since you've got full enrollment and it's a one month primary endpoint that's going to be on the early side in second half rather than the later cycle.
John: Janice.
Speaker Change #115: I think as we've mentioned we've enrolled approximately 2300 patients in the trial. So thats a considerable amount of data that needs to be king.
Janice: We said the second half of the Conrad in Euro queues, knowing exactly when that hits will provide I think more specific guidance I think thats. The best I can do for now.
Speaker Change #116: And don't forget Jon we need to go to 60 days. So also not just 30 days.
Speaker Change #116: And obviously there was a significant cleanup.
Speaker Change #119: So some of them.
Speaker Change #114: Numbers today, we are talking about just for symptom I think 700000.
Speaker Change #122: <unk> report so just to put an example.
Janice: It's clearly.
Janice: Major.
Janice: Understood. Thanks.
Speaker Change #118: Thank you one moment for our next question. Please.
Speaker Change #126: Our next question will come from the line of Tim Lugo with William Blair. Your line is now open.
Tim Lugo: Thanks for taking my question and I know you mentioned you don't want breakthrough easel embargo.
Tim Lugo: Can you discuss the kind of what broadly the fixed dose combo HDD it looks like.
Tim Lugo: Kind of thoughts there.
Speaker Change #132: Dose of 550, Megs once a day and <unk> is 180 once a day is the fix dose.
Speaker Change #132: Roughly a combination of those what's the pill burden look like.
Speaker Change #120: And so yeah, let's just start there.
Speaker Change #128: Sure look.
Speaker Change #120: We.
Speaker Change #131: It would be a tablet.
Speaker Change #129: And we don't want to have a.
Speaker Change #123: A huge tablet the 1213.
Graham: Graham So we believe that two tablets.
Graham: Will it be the.
Graham: The ideal.
Graham: Formulation.
Speaker Change #120: Once a day obviously.
Speaker Change #127: And again we.
Speaker Change #127: We have several formulations.
Speaker Change #127: Have.
Speaker Change #125: Excellent data in dog under several conditions.
Speaker Change #125: We completed already one fixed dose combination, we anticipate two of them one or two more.
Speaker Change #125: Actually the next one will start.
Speaker Change #125: In the next couple of weeks.
Speaker Change #135: So as you can see we wanted to maximize our goal is to get very close to 100%.
Speaker Change #125: Drug exposure for both of them.
Speaker Change #125: And with us.
Speaker Change #138: Without any further fact basically that's how we'll go Tim.
Speaker Change #125: Okay.
Speaker Change #133: It makes a lot of sense and can we expect.
Speaker Change #133: Data, maybe highly lethal but is that the compensated cirrhotic <unk> I know that that seems.
Speaker Change #133: Because they are real unmet need.
Speaker Change #133: Well.
Speaker Change #134: Youre right for the company.
Speaker Change #137: And then see what I think I'll answer.
Speaker Change #130: You want to address that question.
Speaker Change #130: So we are now enrolling conference when you see what is in phase II, but the.
Speaker Change #141: Plans for the content space robotics will be something that we'll do.
Speaker Change #141: Do later.
Speaker Change #130: Okay.
Speaker Change #130: Understood.
Speaker Change #130: Look Tim as you can appreciate that.
Speaker Change #130: And I think thats.
Speaker Change #130: Right now that is not.
Speaker Change #130: Indicated.
D comp: And D comp because of the presence of the Pis.
D comp: We will of and you anticipate that you'll know that.
Speaker Change #139: Fortunately there would be some deaths.
Speaker Change #139: In the phase III was decompensation patients. So it's clear that we want to complete the phase III trial.
Speaker Change #139: And then very likely.
Speaker Change #139: Shortly after it will be a head to head against that.
Speaker Change #139: Patient population cannot ethically.
Speaker Change #139: Placebo control study.
Speaker Change #142: So definitely something that we look forward to move rapidly because of the needs.
Speaker Change #143: Those patients.
Speaker Change #145: Okay. Thank you.
Speaker Change #140: Thank you.
Speaker Change #144: As a reminder to ask a question you will need to press Star 111 moment for our next question.
Speaker Change #148: Our next question comes from Atlanta, Lewis with Leerink Partners. Your line is now open.
Speaker Change #149: Hi, everyone. This is rosa on for on a release a couple of questions on HCV can you have a sense for how large of a safety database your need.
Speaker Change #144: For registration and thinking about the key compensated cirrhosis patients that was mentioned can you give us a sense of that.
Rosa: Percentage of these patients.
Rosa: As they make up like the total HCV population.
Speaker Change #147: Uh huh.
Speaker Change #150: And you want to address the question on place.
Speaker Change #151: Yes, so regarding the safety database for.
Speaker Change #152: Combination antiviral like this usually is around a thousand patients.
Speaker Change #152: Recommended dose.
Speaker Change #153: Len such statement.
Speaker Change #152: So.
Speaker Change #152: That's roughly what the phase III program, we have to have plus what we already enrolled again in.
Speaker Change #147: In phase II.
Speaker Change #169: And the second question was the percentage of the compensations I cannot give you the exact percentage in the United States, but it's really less unless it's really quite feel very strong.
Speaker Change #147: In.
Speaker Change #147: Usually a strong Asian countries, but in the United States. This represents a really small amount of.
Speaker Change #147: Ah patients with HCV right now.
Speaker Change #154: Got it thanks, and then thinking about current rates of hospitalization for COVID-19 are you guys still using the assumption of like maybe 2% to 3% currently.
Speaker Change #154: Janet.
Speaker Change #154: Okay.
Speaker Change #170: We're thinking about it really in the.
Speaker Change #154: The.
Janet M. J. Hammond: In terms of achieving a statistically significant difference in hospitalizations and death.
Speaker Change #154: We are powerful.
Speaker Change #154: Around the center.
Speaker Change #154: Comparable store and other theme.
Speaker Change #155: I think our assumptions on that is now canceled data from nerve naphtha.
Speaker Change #155: I think I think talked about.
Speaker Change #154: And you'll recall we did.
Speaker Change #154: Actual expand the sample size.
Speaker Change #156: Buffy Erika I suppose to accommodate from Rafal.
Speaker Change #163: Got it thanks, and then a last one on your cash runway.
Speaker Change #157: Does your current assumption include.
Buffy Erika: Partnering out your Covid program.
Speaker Change #160: The only option or would you consider or does that build and launching yourself potentially.
Speaker Change #157: Okay.
Speaker Change #156: Andre.
Andre: So it does.
Speaker Change #158: Anticipate that we will have a partner for <unk>.
Speaker Change #158: 19.
Andre: Nonetheless, we do anticipate that there will be some initial commercialization activities, which we individually billing days.
Andre: Including large scale manufacturing.
Speaker Change #159: I may add.
Speaker Change #162: Okay got it thanks, so much that's it for us.
Speaker Change #168: Thank you.
Speaker Change #166: Thank you I am currently showing no further questions at this time I'd like to hand, the conference back to Mr. <unk> for closing remarks.
Speaker Change #164: Again, thank you all for joining our first quarter of 2024 earnings conference call.
Mr. <unk>: Thank you for your continued support.
Mr. <unk>: Yes.
Speaker Change #165: This concludes today's conference call. Thank you for your participation you may now disconnect everyone have a wonderful day.
Mr. <unk>: Okay.
Mr. <unk>: [music].
Mr. <unk>: Okay.
Andre: Yes.
Andre: [music].