Atea Pharmaceuticals Q4 2023 Earnings Call Transcript

Quartr
Provided by Quartr
February 28, 2024

There are 11 speakers on the call.

Operator

Good afternoon, everyone, and welcome to the Atea Pharmaceuticals 4th Quarter 2023 Financial Results and Business Update Conference Call. At this time, all participants are in a listen only mode. Following the formal remarks, we will open the call up for your questions. I would now like to turn the call over to Jonae Barnes, Senior Vice President of Investor Relations and Corporate Communications at Atea Pharmaceuticals. Ms.

Operator

Barnes, please proceed.

Speaker 1

Good afternoon, everyone, and welcome to Atea Pharmaceuticals' 4th quarter and full year 2023 financial results and business update conference call. Earlier today, we issued a press release, which outlines the topics we plan to discuss. You can access the press release as well as the slides that we'll be reviewing today by going to the Investors section of our website at ir. Atayapharma.com. With me today from ATAYA are our Chief Executive Officer and Founder, Doctor.

Speaker 1

John Pierce Amadosi Doctor. Arun Shah Harga Chief Medical Officer Chief Development Officer, Doctor. Janet Hammond Chief Financial Officer and Executive Vice President of Legal, Andrea Corcoran and our Chief Commercial Officer, John Babrieta. They will all be available for the Q and A portion of today's call. Before we begin the call and as outlined on Slide 2, I would like to remind you that today's discussion will contain forward looking statements that involve risks and uncertainties.

Speaker 1

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 Jean Pierre.

Speaker 2

Thank you, Jonelle. Good afternoon, everyone, and thank you for joining us. I will begin on Slide 3. Looking back at our substantial progress throughout 2023, I'm proud of the strong operational execution we achieved across our antiviral programs. The 2023 highlights from our COVID-nineteen program include the ability to leverage global surges to meaningfully advance our Phase III SUNRISE III study.

Speaker 2

This was made possible by the expansion of the global footprint and the broadening of the eligibility criteria for our high risk patients. So far in 2024, we continue to observe encouraging enrollment strength for Sunrise 3. Reflecting the continuing unmet medical need, we were granted fast track designation by the FDA for the evaluation of Benafrazolevide for COVID-nineteen. We have continued to demonstrate that Benafrasimab remained fully active against all variants tested in vitro, including the Noyes subvariants related to the Omicron. The profile for benifosbuvir is supported by robust clinical data, including favorable efficacy and safety with no drug drug interaction.

Speaker 2

We believe that veniprosmabir has the potential to address the key limitations of current COVID-nineteen oral therapies. For HCV, the 2023 highlights include achieving regulatory approvals of a short 8 week treatment for the global Phase II trial of the combination of Benafosbuvir and risasvir for the treatment of HCV The rapid enrollment of the leading cohort, which has led to exciting SVR results that we will review today. We demonstrated in vitro synergy of the combination of Benafrazmivir and Reslovir and the compelling potency profile against major HCV resistance mutations. We are now evaluating several fixed dose combination tablets in preparation for the Phase 3 program and subsequent commercialization. And we presented and published preclinical and clinical data in support of this program.

Speaker 2

We believe Benifrostivir in combination with risasvir can significantly improve upon the current standard of care by offering a differentiated short 8 weeks protein inhibitor free treatment, which has been well tolerated and has limited potential for drug drug interactions. Moving to Slide 4. AteyaVision is focused on the discovery and development of antiviral drugs for the treatment and cure of serious viral diseases where there is a significant unmet medical need and where we can make a huge difference. As you know, we believe that COVID is yet to stay and the recent winter surge remind us that new dominant variants like GN1 are striving despite the latest vaccine booster and treatments. The SARS CoV-two virus is accumulating mutations with amino acid substitutions faster than any other endemic RNA virus, highlighting the desperate need for a broader and more diversified arsenal of safe, well tolerated and easy to prescribe oral anti viral therapeutics.

Speaker 2

Our team continues to efficiently execute our global Phase III trial, and I'm very pleased to announce today that we have achieved another significant clinical milestone and surpassed enrollment of 1400 patients, triggering our 2nd interim analysis in the supportive care monotherapy cohort. This is an important milestone, allowing for the data review by the independent DSMB for safety and fertility. For Sunrise 3A, we anticipate several upcoming events, including the 1st interim analysis in March, the second interim analysis in the Q2 of 2024 and top line results during the second half of twenty twenty four. Penifrostmibin has the potential to address many of the key limitations of current COVID-nineteen therapies, including safety, tolerability and drug drug interactions. Our goal is to deliver best in class treatment to the millions of patients for whom the current standard of care is suboptimal or unsuitable.

Speaker 2

As part of a multi pronged approach against COVID-nineteen, We continue to also make progress with our discovery program focused on a highly differentiated second generation protease inhibitor and we expect to provide an update mid year. For our Phase 2 HCV program, as stated earlier, We shared new results with CONFIRM and 98% SVR4 post treatment in the leading cohort of our Phase 2 combination 8 week study. Arrenza will review these results in more details. Our goal for this program is to substantially enhance the current set of care by offering a short 8 week protease inhibitor free treatment that is well tolerated with low potential risk for drug drug interaction for all HCV patients. Importantly, we are in a strong financial position to execute our strategy with $578,100,000 of cash and cash equivalents as of December 31, with a runway anticipated through 2026.

Speaker 2

Andre will provide a detailed update on Atea's financial position during today's call. I will now turn the call over to Arrenza for an update on our HCV program.

Speaker 3

Thank you, Jean Pierre. Turning to Slide 6. Despite current treatment options, HCV continues to be a health crisis in the U. S. As Jean Pierre noted earlier, there are approximately 2,400,000 people infected with HCV in the U.

Speaker 3

S. Despite availability of oral treatments. Recent trends indicate there are more new infections and reinfections than cures on a yearly basis. And these statistics highlight the need to improve the HCV treatment landscape. The combination of the combination of the hemiprosophir and busasvir 8 week protease inhibitor free treatment with less side effects and a low risk for drug drug interactions.

Speaker 3

Based on our market research with KOLs and high prescribers, these attributes are very critical for a new treatment, as you will see on the next slide. Moving to Slide 7. While the introduction of direct acting antivirals has transformed HCV treatment, significant unmet needs still exist. In recent quantitative market research conducted by Atea with over 150 U. S.

Speaker 3

Physicians who are high prescribers of Epclusa or Mabiret, only 6% of these physicians reported that there are no unmet needs regarding HCV treatment. Key unmet needs emerging in this research were shorter length of treatment and higher efficacy, particularly in HIV co infected patients, as well as fewer contraindications as detailed on the right hand of the slide. Please note that currently approximately 17% of patients do not complete their treatment regimen, makes inconvenient and shorter treatment durations of particular importance to prescribers. Slide 8 outlines our Phase 2 open label study of 550 milligrams of deniphosfibir in combination with 180 milligrams of rosuzasvir once daily for 8 weeks. We plan to enroll up to 280 DAA naive patients across all genotypes.

Speaker 3

In the initial cohort, sustained biological response, or SBR, at week 4 was used as the decision criteria to reinitiate enrollment to complete the Phase II study. The primary endpoint of the study is SVR at week 12, and this will be reported for all patients at study completion. Slide 9 highlights the patient demographics and baseline characteristics in the leading cohort of the Phase II open label study of veniphosphobir and rosasvir. The patients were diagnosed with a median age of 47 years old. This cohort was comprised of non cirrhotic patients only.

Speaker 3

However, please note that 10 patients had fibrosis stage of F3, a more advanced liver disease stage, which is borderline with cirrhosis. In the second part of the Phase II study, compensated cirrhotic patients will also be enrolled. Moving to Slide 10, we are excited to share with you today that the final results from the Phase II combination study in the leading cohort confirmed an SBR4 of 98% post treatment across all genotypes. In January, we reinitiated enrollment to complete the study in up to 280 patients with top line results anticipated in the second half of twenty twenty four. 7 shows the on treatment viral kinetics of individual patient data.

Speaker 3

By week 4, all 60 patients in this cohort had viral load near or below the lower limit of quantification. Therefore, this very rapid kinetics across all genotypes support an 8 week regimen and compare favorably to the only approved 8 week treatment for HCV. On Slide 12, the combination of venifosbuvir and rosuzvir was generally safe and well tolerated in this cohort of 60 patients. There were no drug related serious adverse events, no discontinuation, and adverse events were mostly mild. Turning to Slide 13.

Speaker 3

To summarize our progress in HCV, based on the positive leading cohort data, we reinitiated enrollment in January for the remainder of the Phase II trial. To help advance enrollment and achieve representative genotype distribution, we are increasing this study's footprint to approximately 50 clinical sites in 15 countries. In addition, over the first half of twenty twenty four, we are conducting Phase I studies in the U. S. For the selection of the 6 dose combination tablet, which will be evaluated in the Phase III program and used for subsequent commercialization.

Speaker 3

We anticipate that the Phase III program will be initiated around the end of this year. Slide 14. Next, we will provide an update on our COVID-nineteen program. I'll turn the call over to Janet to discuss our SAND RISE-three Phase 3 trial.

Speaker 4

Thanks, Arantxa. Good afternoon, everyone. COVID-nineteen continues to be an established pathogen of concern according to the World Health Organization. And we believe that COVID-nineteen will remain an ongoing serious endemic issue. Our goal for COVID-nineteen is to deliver a safe and effective treatment to millions of patients for whom the current standard of care is not a suitable option.

Speaker 4

We believe that the compelling preclinical and clinical profile of Benifosbuvir is differentiated with a low risk for drug drug interactions, a favorable tolerability and a high barrier to resistance and has the potential to become the treatment of choice for COVID-nineteen for millions of patients. Moving to Slide 16. Supported by our extensive global footprint, we are seeing robust enrollment into SUNRISE-three and patient enrollment has correlated with the latest winter wave. In particular, we've experienced strong enrollment in the U. S.

Speaker 4

Where sites have been responsible for approximately 75% of the patients enrolled to date. The majority of patients globally continue to be enrolled in the monotherapy cohort despite the availability of other oral antiviral. We're excited to share with you today that Sunrise 3 surpassed enrollment of 1400 patients in the monotherapy cohort, triggering the 2nd interim analysis. The DSMB is expected to meet in March for the 1st interim analysis, and we expect the 2nd interim analysis to occur during the Q2. Just to remind you, the DSMB reviews are primarily geared towards safety and futility.

Speaker 4

So far this winter, as predicted by the U. S. CDC, respiratory diseases are showing similar high trends to last year. The patients most vulnerable to severe COVID infection remain the elderly, the immunocompromised and those with underlying risk factors for severe infection, but oral therapeutics are of critical importance to protect against hospitalization and complications. Turning to Slide 17, I'll now go into detail on our SUMMARIZE-three global Phase III trial.

Speaker 4

To start, our inclusion criteria focus on high risk outpatients with mild or moderate COVID-nineteen, regardless of vaccination status. The symptom onset is 5 or less days before randomization. The Phase 3 study is randomized, double blind and placebo controlled. The study drug either Benicostavia 550 milligrams BID or placebo, is administered concurrently with the locally available standard of care. There are 2 study populations depending on the type of standard of care received.

Speaker 4

The supportive care monotherapy cohort comprises the primary analysis population, while the combination cohort is part of the secondary analysis and includes patients treated with local standard of care, including other compatible COVID-nineteen antiviral drugs. The primary endpoint for the study is all cause hospitalization or death through day 29 in the supportive care monotherapy population, which will be approximately 2,200 patients. The secondary endpoints are COVID-nineteen related hospitalizations and deaths, Medicare attended visits and symptom relapse. Last year, we were granted Fast Track designation for Benefostavir, reflecting the recognized unmet medical need that remains for COVID-nineteen patients. Overall, we're seeing strong operational execution for SUNRISE 3 from our clinical team with robust enrollment trends.

Speaker 4

I'm now going to hand the call over to John to discuss the marketing opportunity for Benfosbuvir. John?

Speaker 5

Thank you, Janet. Turning to Slide 19, we know that the U. S. Prescription demand for oral antivirals to treat COVID correlates with the infection rates. The demand for oral antivirals in 2023 was very robust with a total of approximately 7,700,000 scripts written.

Speaker 5

Last month, the scripts were approximately 920,000, which reflects the latest winter surge. On the next slide, Slide 20. Late last year, the market for COVID-nineteen oral antivirals began transitioning to traditional payer markets such as Medicare, Medicaid and private commercial insurance. Oral antiviral therapeutics for COVID-nineteen are expected to remain a multi $1,000,000,000 opportunity for years to come. Projected annual COVID-nineteen oral antiviral U.

Speaker 5

S. Demand using IQVIA retail prescriptions suggest an estimated annual global market opportunity of over $4,000,000,000 to $5,000,000,000 with only 2 products that each have key limitations. We believe there is still an unmet need with critical gaps and there is the opportunity to expand this market to patients due to drug drug interactions and tolerability with PAXLOVID and safety issues with LIGAVRIO. I'll now turn the call over to Andrea to discuss the TAEUS financials.

Speaker 6

Thank you, John. As Jonae mentioned, earlier this afternoon, we issued a press release containing our financial results for the Q4 and full year 2023. The statement of operations and balance sheet are on Slides 2223. There was an increase in R and D expense for the Q4 and full year 2023 versus the corresponding periods in 2022. The primary driver for the higher expense was the external expense related to our COVID-nineteen Phase 3 SONRISE 3 clinical trials and our Phase 2 clinical trial of the combination of Benafosbuvir and rosuvir for the treatment of hepatitis C.

Speaker 6

General and administrative expenses remained relatively flat for the Q4 and full year versus the corresponding periods in 2022. Interest income increased for the Q4 and full year 2023 versus the corresponding periods in 2022. This was the result of investing in higher yield marketable securities and higher interest rates. At the end of the Q4 of 2023, our cash, cash equivalent and marketable securities balance, as Jean Pierre mentioned, was $578,100,000 Based on our current plans, we are reiterating our cash guidance with a runway through 2026. I'll now turn the call back over to Jean Pierre for closing remarks.

Speaker 2

Thank you, Andrea. In closing, following a year of solid operational execution across our 2 clinical programs, Our clinical momentum set us up for a transformational milestone rich 2024 for both our COVID-nineteen and HCV program. For COVID-nineteen, we anticipate meaningful clinical milestones beginning in the Q1 of 2024 with the 1st interim analysis from our global Phase 3 trial, followed by a second interim analysis in the Q2 of 2024. Top load results as expected in the second half of twenty twenty four. For HCV, we anticipate completing enrollment of our Phase 2 study and reporting results during the second half of twenty twenty four.

Speaker 2

We have continued to target initiation of a Phase 3 around the end of the year and we are extremely encouraged by the SVR4 and safety results in the leading cohort. We are targeting multibillion dollar markets, each of which are currently comprised of only 2 primary products. We believe that our product candidates are very differentiated and have the opportunity, if approved, to fill the gap in the current unmet medical needs and become blockbuster products. We are very excited about the opportunities ahead and are confident in our ability to develop and commercialize innovative products and create meaningful shareholder value. In particular, I'm very proud of the team hard work throughout the year.

Speaker 2

Apera is a company with less than 80 employees, which is conducting 2 global studies in disease with multibillion dollar market opportunities with a high degree of efficiency as well as with significant financial discipline. With that, I will turn the call back over to the operator.

Operator

And our first question will come from Eric Joseph of JPMorgan. Your line is open, Eric.

Speaker 7

Thank you. And thanks for taking the questions. A couple from us. Just on the sizable accrual in patients for Sunrise 3, do you have visibility in terms of, I guess, how those are apportioned across the different study arms, monotherapy versus combo? I guess what visibility do you have in terms of percent to enrollment completion of the monotherapy primary analysis population?

Speaker 7

And on the HCV side, just picking up on a comment you made, JP, about potentially being a non protease based inhibitor option. What's the significance of that? Is there sort of a safety advantage that you'd highlight? Or is it more about just being an alternative mechanism compared to the other commercially available wheat regimen? Thanks.

Speaker 2

Thank you, Henrik. There is definitely an importance in the differentiation, but let's start with the COVID-nineteen questions. Great question. Janet, do you want to give a little bit some granularity to Eric?

Speaker 3

Sure. Thank you, Eric, for

Speaker 4

the question. So in regard to how the patients are apportioned to the combination versus monotherapy, I mean, obviously, 1st of all, just to say that this is at the discretion of the investigator and prescriber who sees the patient, and they are encouraged to prescribe combination therapy if they believe that is appropriate for the patient and are actually educated quite extensively at our investigation meetings in that regard. And what I think is quite surprising is that the vast majority of patients are actually being assigned to the monotherapy arm. And I think reasons for this probably are really the extensive potential for drug interactions associated with ritonavir in the paclovid combination treatment, which I think deters people from prescribing combination therapy to patients. And then in regard to your question around when we if we have any visibility as to when we might complete accrual in the monotherapy arm, no, we don't.

Speaker 4

But I can say that enrollment is proceeding well. But of course, we're very dependent on the fluctuations in COVID cases as they occur. We've seen a very strong winter season. But frequently, I think at least in the past, we've observed that that's followed by some downward trend in the number of cases until we get towards the hotter summer months when people move indoors again. So we're somewhat dependent on that, we'll have to see.

Speaker 4

Thank you.

Speaker 2

So related to the HCV questions, I think with the survey from a third party, really exemplify the importance of the lack of protease inhibitor in the combination treatment, especially when we are talking about 40% of HIV infected patient with HCV, where you're going to have substantial drug drug interaction if we have if you have a protease inhibitor. So it is an important differentiation. John, you want to maybe also expand on that and really this is not just a gimmick here that we are talking, but really importance from a commercial standpoint. And then I will ask our answer from a patient standpoint. John, you want to address that from a commercial standpoint?

Speaker 5

Sure. So Eric, from a commercial standpoint, obviously, being Protea 3 is really important to us for the low low drug in our GDI interaction potential. And also it there's also other advantages such as having a no food effect and also to be able to treat with a shorter treatment duration, particularly important because as Arantxa mentioned earlier in the presentation, what clinicians are finding is that the shorter time to treat is the better. And to highlight this about Mabaret has obviously a protease inhibitor. And when you look at the NewRx market shares, even despite being 8 weeks versus 12, there's almost a little bit more than a 10 point share difference in favor of Eclusa.

Speaker 5

And so that should maybe also tell us some things as well.

Speaker 2

Our answer from a patient standpoint after your discussion with KOL and prescriber, go ahead.

Speaker 3

Yes. So from a medical perspective, I think what we're trying to develop here is really a best in class regimen that combines the best of Eclusa and the best of Mavyret in the sense that it's an 8 week regimen. And without the drug drug interactions that are actually quite common that Maberate and protease inhibitors have as a class. And these are common drugs. We're talking about things like contraceptives, antiretroviral therapy, statins, proton pump inhibitors, which almost everybody over 40 something like that.

Speaker 3

So this is very important for the patients as the market research has indicated. But also when we talk to the KOLs on the field and when they were actually trying to review our protocol and participate in our clinical trial, all of them were very excited that we could actually develop this best in class regimen bringing the best of both attributes of both regimens.

Speaker 2

Thank you, Arendt sir.

Operator

And one moment for our next question. And our next question will be coming from Maxwell Skoure of Morgan Stanley. Your line is open Maxwell.

Speaker 8

Great. Thank you for taking my questions. Given your strong financial position, I was hoping you can elaborate a bit on your capital allocation strategy and how you're preparing for potential launch in COVID while advancing your global HCV program. Basically, how should we think about spend over the next several quarters? Thank you.

Speaker 2

Andrea, you want to address the question? Maybe just I'd like to indicate that for the launch, we have actually supply. If we are fortunate to get an approval in the U. A, but we will not put substantial investment in manufacturing at risk prior to approval. So we will provide additional information as we get closer to launch.

Speaker 2

So with that, to this, Andrea? Yes.

Speaker 6

Thank you, Jean Pierre, and thanks, Max, for the question. So I think as you've seen or will see when you have the chance to review the financial statements, We continue to exercise really discipline in our investments for both the COVID-nineteen program as well as the hep C program. Expenses are increasing, but in a very measured way quarter over quarter for 2023. We would expect the same type of limited increase in 2024. The Phase 3 program for COVID will begin to wind down before the Phase 3 begins for hep C.

Speaker 6

But nonetheless, we will be preparing for commercialization, as you said. So there will be additional activities and that we will be funding at that point. So the expenses for 2024 and 2025 are expected to increase, but in a very measured way.

Speaker 8

Great. Thank you.

Operator

And one moment for our next question. And our next question will be coming from John Miller of Evercore ISI. Your line is open, John.

Speaker 9

Hi. This is Jessica on for John Miller. Thanks for taking our questions. I have two questions, if I may. 1 on COVID, 1 on the hep C front.

Speaker 9

So for COVID, so you said SUNRISE-three top line data expected in second half of the year. So how should we think about the various scenarios that can occur? Like how well does the market appreciate that pre existing immunity from infection and or vaccination can affect placebo rates, possibly making the effect size smaller? And maybe a direct comp to PAXLOVA trial data may be limited. And then also worst case scenario, how should we think about the company direction in the bear case scenario that the primary endpoint is not met?

Speaker 9

And then I have a follow-up question. Thank you.

Speaker 2

Jan, would you like to address the question, please?

Speaker 4

Thank you, Jessica. So, yes, I think everybody realizes that with vaccination and prior exposure to COVID-nineteen, the severity of disease is frequently less severe, fortunately, than it was when we were going through, in particular, I think the delta wave and hospitalizations were at an all time high. Our study is designed to show a delta in efficacy comparable. So I think what Pfizer most recently reported in their outpatient study where there was about a 50% or in the 50s difference between the active and the placebo groups. And so that's what we're expecting to see.

Speaker 4

I think particularly when you're talking about high risk patients and hospitalizations, that is still an important and meaningful difference. And of course, hospitalization and death are the worst outcomes. And so if one can prevent those and reduce the severity of disease, I think that's going to be really important.

Speaker 2

Just to add go ahead, Jen. Sorry, go ahead.

Operator

No, I was

Speaker 4

just going to ask you if you wanted to follow on with Jessica's other question around the scenario where we failed to achieve a primary endpoint.

Speaker 2

Yes, go ahead.

Speaker 4

Okay. So I think I mean, certainly, I mean, it's one of those things that is under consideration is if we're unable to do that, are there further avenues to pursue in terms of looking for trends? And we have a fast track designation with FDA to assess how to proceed. But we also have, as I think has been mentioned, 2 interim analyses, where the DSMB will help us to make the decision not to proceed should we see that no number of patients in what we are projecting would allow us to be successful. So I think those are the scenarios that we're certainly aware of and thinking about.

Speaker 4

But at the moment, things are moving forward well, and we look forward to presenting results and I'll continue to update as we move forward.

Speaker 2

Thank you, Janet. And just what I wanted to add to the first question is, I think it was it's very telling that the NIH actually recently reported that only 15% of high risk actually are taking Paxlovid. And actually so 85% of eye risk who should get an oral therapeutic don't. Well, very likely many of the reason of the limitation of PAXLOVID. So you can see that there is a huge opportunity for a best in class product and including even with the challenging that the challenges that we face, as Janet and Jessica, you recognize in term of number of low event, but we believe that the way the study has been built will maximize the results for the efficacy and safety of this drug.

Speaker 2

So I understand you may have another question on HCV as well?

Speaker 9

Yes. Thank you. So, on the hep C program, given the context that compliance with existing therapies is lacking with existing regimens, so there's an unmet need here. And the patients you're presumably going after are the ones that we know already are bad at compliance or else they'd be cured already. How do you guys plan to ensure for the Phase 3 that the protocol and clinical sites can optimize good drug adherence, especially since we've already seen that one patient in Phase 2 report here and who is thus unable to achieve SVR4?

Speaker 2

That's a great question, Jessica. Eransa, we spent quite some time on that. So Eransa, you'd like to address the question?

Speaker 3

Yes. It is a great question. I think in part, the compliance issues are just part of the nature of doing trials right now in Hepatitis C. The population that we have that is in high unmet need right now is a bit of a mix of the patients who are not taking drugs and they are just general patients. But also there is a very large population of patients that are ex IV drug users or IV drug users.

Speaker 3

And those really benefit from short treatment durations. So I think by offering a short treatment duration, you're already addressing some of the compliance issues because patients in general are very excited to take drugs at the beginning, but then sometimes they forget towards the end of the treatment. I think we have all experienced that. So the 8 week duration already helps. We of course, have the regular measurements of checking with the patients, calling them, bringing them in.

Speaker 3

Very important in Phase 3 is that we're going to have a comparator. So the issues with compliance will affect both arms equally because the patients are randomized. And there you're really going to see how the comparator is behaving in today's kind of population, which includes these patients that are non compliant in general?

Speaker 2

Yes, obviously, we will finalize any protocol with the regulatory authorities. So but based on our initial interaction, it's clear that a competitor is required for our Phase III program.

Speaker 9

Thank you very much.

Operator

And one moment for our next question. And our next question will be coming from Roanna Ruiz of Leerink Partners. Your line is open.

Speaker 10

Thank you. This is Rosa Chen on for Roan Ruiz at Leerink Partners. Just a couple from us. First on COVID. So thinking of all the various high risk patients you're enrolling in Sunrise 3, which of the population do you think that nifosbuvir can offer the most differentiated profile from currently available antiviral?

Speaker 10

And any thoughts on how you could leverage the data from the combination therapy arm?

Speaker 2

Janet, you'd like to address the question, please? Sure.

Speaker 4

So, I think with regard to the high risk patient population, I mean, it's quite interesting that I think in the last few months, there have been a couple of publications really showing that for the most high risk patients, the elderly, particularly I think there's 75 and above, and those that are highly immunocompromised. And I think in that regard, particularly solid organ transplant patients, however many times they get vaccinated, it doesn't really seem to reduce their risk of getting severely ill when they do become infected with COVID. So I think these are the patient populations which are probably the ones where there is likely to be the greatest benefit. And I think another reason why ultimately, I mean, I think would be an ideal drug for patients such as these is that these are patient populations that are on multiple concomitant medications. And as Jean Pierre mentioned, and as we've alluded to, I think the potential for drug interactions, particularly with protease inhibitors is much higher than with nucleoside antagonists.

Speaker 4

And so I think these are the patient populations where frequently they're actually ineligible to receive a drug such as Paxlovid and have been in the past fortunate enough to have been able to receive monoclonal antibodies. But as you know, the monoclonal antibodies haven't been able to keep pace with the evolution of the virus. And then with regard to the combination group and what we're going to do there to educate ourselves, it's really most important, I think, because we have, as Jean Pierre mentioned in his remarks, a protease inhibitor, which is being developed and which we hope to show more information for later in the year. And so I think being able to see how combination therapy and in particular Aprociate inhibits her in combination with bengifrostevare is able to provide synergy and potentially reduce various symptoms and allow patients to improve better. And also, we're going to be looking at such things as drug interactions and viral load kinetics and safety and tolerability.

Speaker 4

I think all of that information is important in understanding how best to use these drugs and maximize them as we move further down the line. Thank you.

Speaker 10

And then on HCV, how should we think about the PK and efficacy of and the patient population that actually has compensated cirrhosis compared to those without cirrhosis in your lead in cohort? And then are you considering including patients with decompensated cirrhosis and also HIV co infection in your Phase 3, so it's a similar well, to pursue a similar label as EPCUSA? And then separately, who are these low hanging fruit patients that you could target if it's approved?

Speaker 2

Sure. Ernesto, maybe you want to start to address the question and then maybe a comment as well. So, Arrenza?

Speaker 3

Yes. Well, I think the PK, we don't anticipate major changes in PK or even PKPD and viral kinetics. As you saw in the data that we have shown, the kinetics were very fast, even in the F3s, which are really borderline compensated cirrhotic. So we think that we've seen also in previous trials that the PK should be the same. That is for the compensated cirrhotic.

Speaker 3

For the decompensated cirrhotic, it's a great population. I think that we are going to target it. It's probably a little bit later. For the HIV, certainly, we are considering inclusion in Phase 3 trial. It's like you said, a great unmet need population.

Speaker 2

Yes. No, actually, just one comment for the decompensated patient, obviously, that would be, we believe, a major advance because we foresee at least we see the potential to eliminate rebavirin, which right now you have only one approved treatment, which is a combination of Epclusa and rebavirin in those patients. Now let's not forget that this is a patient population that is very difficult, very likely in the trial you're going to have some deaths. So obviously, we foresee that this population will be very likely not part of the Phase 3 program unless the regulatory authorities will request that, but more as a post NDA commitment. But definitely, we definitely want to go there, maybe not with 8 week, probably a 12 week would be already highly differentiated with the elimination of rebavirin.

Speaker 2

And obviously, these patients do require the best chance of success and that the length of treatment are less of an importance than what we have with the patient population that Irante just shared with you before.

Speaker 10

Got it. Thanks so much for taking our questions.

Operator

You're welcome. I would now like to turn the conference back to Jean Pierre for closing remarks.

Speaker 2

Thank you all for joining our Q4 and full year 2023 earnings conference call, And thank you as well for your continued support.

Operator

Ladies and gentlemen, this concludes today's conference. You may now disconnect.

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Key Takeaways

  • Atea’s COVID-19 antiviral candidate, benifosbuvir, has enrolled over 1,400 patients in the Phase III SUNRISE III monotherapy cohort, triggering a second interim analysis with the first DSMB review in March and top-line results expected in H2 2024 under a Fast Track designation.
  • The Phase II trial of venifosbuvir plus rosulavir in HCV showed a 98% SVR4 rate post-treatment in a 60-patient non-cirrhotic cohort, with no serious drug-related adverse events, and enrollment has resumed toward 280 patients ahead of a planned Phase III start at year-end 2024.
  • Atea finished 2023 with $578 million in cash, equivalents and marketable securities, sustaining a projected financial runway through 2026 while continuing disciplined R&D investment in its two global antiviral programs.
  • The global market opportunity for oral antivirals remains multi-billion-dollar for both COVID-19 (estimated $4–5 billion) and HCV, driven by unmet needs in safety, drug–drug interactions, shorter treatment durations and efficacy in high-risk or co-infected patients.
  • Operating with fewer than 80 employees, Atea is executing two worldwide clinical trials with efficiency and is advancing a second-generation COVID-19 protease inhibitor in discovery, with an update expected mid-year.
A.I. generated. May contain errors.
Earnings Conference Call
Atea Pharmaceuticals Q4 2023
00:00 / 00:00