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Ladies and gentlemen, thank you for standing by. Welcome to Atea Pharmaceuticals First Quarter 2026 earnings conference call. At this time, all participants are in a listen only mode. A brief question and answer session will follow the formal presentation. If you should require operator assistance during the conference, please press star zero on your telephone keypad. I will now turn it over to the Atea management team. Please go ahead.

Hi. Thank you, operator. Good afternoon, everyone, and welcome to Atea Pharmaceuticals first quarter 2026 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 visiting the investor section of our website at ir.ateapharma.com. With me today from Atea are our Chief Executive Officer and Founder, Dr. Jean-Pierre Sommadossi; Chief Development Officer, Dr. Janet Hammond; Chief Commercial Officer, John Vavricka; Chief Medical Officer, Dr. Arantxa Horga; and Chief Financial Officer and Executive Vice President of Legal, Andrea Corcoran, who will all be available for the Q&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.

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.

Thank you, Jenny. Good afternoon, everyone, and thank you for joining us. I will begin on slide 3. With two pivotal phase III top-line readouts for our global phase III HCV program ahead of us, 2026 will be a catalyst rich year for Atea. We remain on track and are very encouraged by the substantial progress our team continues to achieve. We completed patient enrollment for C-BEYOND, our North American trial, late last year with over 880 patients who are representative of the genotypes and demographics is in North America. For C-FORWARD, our ex-North America trial, I'm pleased to share today that we have completed enrollment for 95% of the cirrhotic and non-cirrhotic patients and anticipate to complete enrollment next month as scheduled.

Currently, enrollment is only open to the less prevalent genotypes such as 4, 5, and 6, which will allow us to support a broad label. This set up two important phase III milestones. We expect top-line data from C-BEYOND in mid-year, as we have reported before, and top-line data from C-FORWARD around year-end. Late last year, we expanded our antiviral hepatitis pipeline to address a major unmet medical need for immunocompromised patients living with chronic hepatitis E infection, a liver disease for which there is currently no approved therapy. If left untreated in this at-risk population, it can rapidly progress to cirrhosis within only 3 to 5 years. We have completed CTA-enabling studies for AT-587, our lead product candidate, and we anticipate to initiate a first-in-human study mid-year.

Initial results were presented in February at CROI 2026, and additional data will be presented at EASL later this month to support AT-587 as a potential first in class inhibitor against hepatitis E infection. I will review this exciting program and our clinical plan for a first in human study later in this presentation. Importantly, with $256 million of cash equivalent and marketable securities as of March 31st, 2026, we are in strong financial position to execute and complete our phase III HCV program and advance our new HEV development program. We anticipate our cash runway remaining through 2027. With that, I will now turn the call over to Janet to review the profile of our regimen.

Thanks, Jean-Pierre. On slide 5, we are conducting the first active controlled phase III global program for hepatitis C, comparing our regimen against the current standard of care, the sofosbuvir and velpatasvir, which is marketed as Epclusa. The data generated to date for the regimen of bemnifosbuvir and ruzasvir support a differentiated potentially best-in-class profile, combining high efficacy, short treatment duration with a low risk for drug-drug interactions, dosing convenience and no food effect. Recent results demonstrate a low risk for drug-drug interactions with proton pump inhibitors, which are taken by estimated at least 35% of hepatitis C patients. We've also confirmed the absence of interaction with HMG-CoA reductase inhibitors or statins, another important and commonly prescribed class of medications.

In closing, I'm also pleased to share that we will be presenting additional results at EASL later this month that support the potential for a best-in-class profile for our regimen. I'm going to hand the call over now to Arantxa to review our Phase III program for the treatment of hepatitis C. Arantxa?

Thank you, Janet. Moving ahead to Slide 7, as a reminder, C-BEYOND enrolled patients in the U.S. and Canada, C-FORWARD is enrolling patients in 17 countries outside of North America. Combined, we expect to enroll more than 1,760 patients in our Phase III program. Both trials are open label, randomized one-to-one against the active comparator and stratified by cirrhosis status and genotype, including patients co-infected with HIV. In patients without cirrhosis, treatment duration is 8 weeks with bemnifosbuvir and ruzasvir and 12 weeks with the standard of care. Patients with compensated cirrhosis receive 12 weeks of treatment with either regimen. The primary endpoint for both studies is sustained viral response or cure 24 weeks after treatment initiation.

Slide 8 shows that the geographic footprint of our global phase II program was comprised of approximately 120 clinical sites in the U.S. and Canada for C-BEYOND and another 120 clinical sites in 17 countries outside of North America for C-FORWARD. We completed patient enrollment of our C-BEYOND trial in December with more than 880 patients, and we anticipate top-line results mid-year. C-FORWARD has a broader global geographic and genotypic footprint, and we expect to complete enrollment mid-year and to report top-line results around year-end. As JP mentioned earlier, we are pleased to share that for C-FORWARD, we have completed enrollment of 95% of the trial in cirrhotic and non-cirrhotic patients. Enrollment is only open to the less frequent genotypes such as 4, 5, and 6, which will support a broad label.

Enrollment of C-FORWARD remains on track to be completed by mid-year. On Slide 9, let's review the Phase III endpoints, patient population, and data analysis for our global Phase III program. In C-BEYOND, the primary endpoint will be analyzed in a modified intent-to-treat or mITT population as preferred by the U.S. FDA. The analysis will include patients that have been randomized and those regardless of drug adherence or loss to follow-up. The statistical analysis will be based on an imputation model with success or failure depending on PCR value, whether negative or not prior to patient treatment discontinuation. A key secondary endpoint will be the SVR rate in the per protocol population.

In C-FORWARD, the per protocol population will be analyzed as the primary endpoint, as preferred by the EMA, and the SVR rate will only include patients who are at least 80% adherent as measured by pill count and have an SVR assessment at week 24. A key secondary endpoint will be the SVR rate in the mITT population. The same methods for assessing non-inferiority will be conducted in both phase III studies and in both patient populations. The phase III studies are powered 90% with 5% non-inferiority margin, with expected rates about 95% in a modified intent-to-treat or mITT population. Using these two approaches in a post-hoc analysis of the phase II results, the SVR rate was 95% in an mITT population and 90% in the per protocol population. I will now hand the call over to John Vavricka, our chief commercial officer.

John?

Thank you, Arancha. I'll begin on Slide 11. HCV remains a significant global healthcare crisis with an increasing incidence of infections despite the availability of direct-acting antivirals for the past decade. Currently in the U.S., out of a reported 160,000 new chronic infections, only approximately 85,000 patients are treated annually. In the U.S., it's estimated that up to 4 million people are infected with HCV. The unrelenting high rate of new chronic HCV infections, which continues to outpace the number of patients being treated, underscores the need for a new differentiated and optimized therapy. Most countries worldwide, including the U.S., are not on track to achieve the World Health Organization's goal of HCV elimination by 2030. In fact, current estimates suggest we may not even achieve this goal by 2050.

HCV is also a leading driver of liver-related morbidity in the U.S., including progression to cirrhosis and liver cancer, reinforcing the importance of expanding diagnosis and treatment. Moving to Slide 12, the U.S. HCV market remains substantial, with approximately $1.3 billion in annual net sales, about 50% of the roughly $2.6 billion global market, reflecting the size of the opportunity. In our discussions with healthcare providers, we consistently hear that a point of care test and treat approach where testing, diagnosis, and treatment initiation occur in a single setting can significantly reduce delays in care and minimize patient drop-off before treatment begins. This model has broad support, including from the CDC, and is gaining momentum through bipartisan efforts to achieve HCV elimination in the U.S.

Key opinion leaders believe it can be an important lever to help increase the number of patients treated and support HCV elimination efforts. They continue to emphasize the need for therapy designed to integrate smoothly into this care pathway. Let's turn to slide 13. This slide summarizes the U.S. HCV payer mix and expected access dynamics. Medicaid represents just over half of DAA volume, with Medicare and commercial plans accounting for the balance. On the right, payer research shows a favorable outlook for PERI access at parity net pricing across all 3 segments, with meaningful concentrations of Medicare, Medicaid, and commercial payers indicating they would be very likely to add another option. Overall, these data support our view that BAM-RZR could achieve broad formulary inclusion subject to regulatory approval. Slide 14. This slide highlights the competitive positions for the U.S. HCV market today.

You can see that Epclusa and Mavyret drive value from different payer mixes, Epclusa skewing more heavily towards Medicare, while Mavyret is concentrated in Medicaid. Let's move to slide 15. Using our phase II results, IQVIA conducted an independent quantitative market research study with 153 U.S. high prescribers. These physicians indicated that they would likely prescribe BAM-RZR regimen to approximately half of their patients, and the results were similar for all patients, regardless of their cirrhosis state. On slide 8, based on the U.S. HCV market dynamics, we believe we can be well-positioned for a capital-efficient commercial launch. Prescriber base is highly concentrated, roughly 7,800 physicians, write about 80% of all DAA prescriptions, so we can reach the vast majority of the market with a specialty sales force of approximately 75, including sales representatives, sales management, and medical science liaisons.

With no other candidates in late-stage clinical development, bemnifosbuvir and ruzasvir enters a market primarily served by only 2 regimens. On the supply side, all components and processes for large-scale manufacturing are in place, and the commercial launch supply production is already underway with a low cost of goods relative to expected net pricing. The 4-week dosing blister card packaging supports patient convenience and adherence. Taken together, we believe the concentrated prescriber base, focused commercial infrastructure, and favorable manufacturing economics position us for a short time to profitability following NDA approval. I will now hand the call back to Jean-Pierre Sommadossi to review the HEV programs.

Thank you, John. Let's move to slide 18. Hepatitis E virus, or HEV, is an acute and a chronic liver disease. In developing countries, genotypes 1 and 2 are most prevalent, and the virus is transmitted primarily through contaminated water, leading to epidemics of acute self-limiting viral hepatitis. In developed countries, and mostly U.S. and Europe, genotype 3 is the most prevalent and is primarily transmitted through contaminated food such as undercooked meat. This genotype can cause chronic hepatitis in immunocompromised patients, which can progress to cirrhosis within a short time of 3 to 5 years. As you may know, this is far more aggressive than what's occur with hepatitis C or hepatitis B, where it takes 15 to 20 years or even longer. Moving to slide 19.

In recent years, with the increasing number of patients who are immunocompromised, including solid organ transplant recipients, hematopoietic stem cell transplant recipients, as well as patients with hematologic malignancies such as multiple myeloma, there's been a growing incidence of chronic hepatitis C infection in the U.S. and Europe. Currently, the standard of care include reducing immunosuppression and/or off-label ribavirin administration, which both present challenges leading to a real opportunity for an effective direct antiviral drug. On slide 20, each year in the U.S. and Europe, 3% of approximately 450,000 patients who have this underlying medical condition are at risk to develop chronic hepatitis E. The unmet need for this patient population potentially represent a market opportunity between $750 million-$1 billion each year. On slide 21.

This slide highlights the preclinical data for AT-587 as a potential first-in-class direct-acting antiviral for chronic hepatitis E. In the genotype 3 replicant in vitro model, AT-587 demonstrate the greatest potency, and importantly, this antiviral activity has also been confirmed in primary human hepatocytes, the target organ for hepatitis E replications. In vitro data also indicate low potential for drug-drug interaction, which is important for this immunocompromised patient who for some take lifelong therapies. On slide 22, today, AT-587 has a clean in vitro and in vivo safety profile. CTA-enabling GLP toxicology and safety pharmacology studies are completed, allowing us to advance to phase I studies and positioning this product candidate as a first-in-class direct-acting antiviral for chronic hepatitis C infections.

On slide 23, the verging PK data in non-human primates and through modeling, we can predict that plasma exposure in humans will exceed the in vitro EC50 against hepatitis E replication in vitro across the internal administration at pharmacologically relevant dosing. On slide 24, this slide outlines a synopsis of our first in-human study for AT-587. The study will be conducted in healthy volunteer with the primary objectives of evaluating safety, tolerability, and pharmacokinetics. It's a randomized double-blind placebo-controlled design with sequential dose escalation and an embedded proof-of-effect assessment. We have incorporated standard sentinel dosing and gated escalation with dose progression informed by real-time safety and PK review. The study includes both single-ascending and multiple-ascending dose phases, providing flexibility to refine those levels as data emerge. I will now turn the call over to Andrea to discuss Atea financials.

Thank you, Jean-Pierre. As Jonae mentioned in her introductory remarks, earlier today, we issued a press release containing our financial results for the first quarter 2026. The statement of operations and balance sheet are on slides 26 and 27. We are pleased to report that our cash and investments were $256 million at March 31, 2026. The funds expended in the first quarter were principally directed to the advancement of our HCV program, evaluating the combination regimen of bemnifosbuvir and ruzasvir, and to the completion of the CTA-enabling studies and manufacture of clinical trial material of AT-587, our product candidate for the treatment of HEV. For R&D expenses, quarter-over-quarter, there was an increase in 2026 compared to 2025.

The net increase in 2026 was principally driven by an increase in external spend related to our HCV phase III clinical development and HEV preclinical development, offset by lower internal expenses, primarily related to a decrease in stock-based compensation and lower payroll and payroll-related expenses. For G&A, quarter-over-quarter expenses decreased. The net decrease was primarily related to lower salaries and wages, lower stock-based compensation expense, and lower professional fees. In 2026, we intend to maintain our rigorous financial discipline while remaining laser-focused on execution and value-creating advancement of our HCV and HEV product candidates. As we complete our phase III trials, prepare to submit our regulatory filings, and engage in pre-launch activities, including the manufacturing of commercial launch supply, the substantial majority of our spending in 2026 will remain focused on the advancement of our hepatitis C program.

With the resources in hand at the end of March, we expect to realize value-creating milestones for both our hepatitis C and our hepatitis E programs. We project our cash runway to extend through 2027. I'll now hand the call back to Jean-Pierre for closing remarks.

Thank you, Andrea. In closing, 2026 is set to be a pivotal and value-creating year for Atea. We remain on track to deliver top-line phase III result from C-BEYOND in mid-2026, followed by top-line phase III results from C-FORWARD around end of the year. We believe the target profile of our regimenHigh efficacy, short treatment duration, a low risk of drug-drug interaction, and convenient dosing with no food effect position us to meaningfully address the needs of today's patients and prescribers. We believe our regimen fits seamlessly within the test and treat model of care, which has the potential to expand the number of patients treated and accelerate progress toward the goal of HCV eradication in the U.S. and globally.

Our HEV program is a strategic expansion of our antiviral pipeline aimed at addressing a major unmet need for highly vulnerable patient population with no approved treatment options today. We anticipate initiating our first in-human study midyear, followed by the initiation of approval concept study around year-end. With that, I will turn the call back over to the operator.

Our first question is from Jonathan Miller with Evercore.

Hi, guys. Thanks so much for taking my question and looking forward to the upcoming data. Let's start with that. I guess to what extent or what should we expect from the top line announcements for C-BEYOND and then later in the year for C-FORWARD? What sorts of data should we expect in a top-line press release versus what would be withheld for later publication at a medical meeting or in a peer-reviewed setting? A.

Second, when we think about commercial launch cadence and potential there, assuming the phase III bear out the differentiated product profile that you guys have been telling us about for a while, to what extent is commercial adoption going to be gated by contracting or by lumpy elements of getting your regimen in place in a program or a test to treat initiative that might have requirements on the drugs it chooses?

Well, thank you, John. Okay, I will address the first question. The first question, we will release as data with the CBR, the primary endpoints, and the key secondary efficacy endpoint. The SVR at week 24 after initiation of treatment in the mITT population as well as the SVR at week 24 in the per-protocol population. John, you want to address the second part of the question?

Sure. John, thank you for the question. You know, currently our launch preparation are currently underway, and that includes, you know, the analysis and evaluation of the marketplace and understanding currently where the business segments are coming from, where likely future growth will coming from, and also looking at where we will focus our activities. That would be including across 3 segments from a commercial perspective of payers in terms of who we'd wanna target and what their formulary status is right now and all those associated timelines, as well as, you know, preparations for Medicaid and Medicare areas. The activities we will start executing them upon the data of our phase III trials.

Part of the question that you asked in terms of understanding what those timelines are and so forth, we will be evaluating all of that as we put into our penetration segments for the market.

Great. Thanks so much.

Thank you.

Our next question is from Maxwell Skor with Morgan Stanley.

Hello, this is Selena on for Max. Thanks for taking our question. With your market research based on phase II results, what could you see in the phase III that you would expect to impact prescriber or payer response?

Arantxa, you want to address that question?

Uh, uh, how-

Should I, like?

Go ahead.

Hello?

Yes. With your market research being primarily focused on, like, the phase II results, what could you see in the phase III results that you think might impact the prescriber or payer response?

I think we see things along the same, you know, trends that we saw in phase II, which is great efficacy with low potential for drug-drug interaction or food effect, et cetera. Data consistent with phase II, which is what we see always in infectious diseases. The phase II data translates very well into phase III. I don't know if John wants to add something to this.

No, I think I'm fine. You know, obviously we used the phase II data and that data was very well received. The only thing I'll tell you is that the payers and other others are also very much interested in having a head-to-head trial 'cause it's the first time, and it was something that's very intriguing and important to them as well. It plays into the previous question about being ready for launch readiness. You know, one of those factors when you talk to the payers also is the head-to-head trial is very helpful to them.

Thank you. Our next question comes from Andy Shay with William Blair.

Thanks for taking our questions. First one, it has to do with C-BEYOND. Looking at the modified intent-to-treat population analysis plan, I think you basically calculated an SVR12 of 95%, based on the phase II study. Looking across the landscape, I believe Gilead published some of the non-compliant SVR12 rates before, and it's in the low 90s, depending on the trials that you're looking at. I'm curious about your thinking in terms of a superiority claim, based on that delta. Just maybe, you know, commenting on the powering and sample size to see, you know, what level of confidence you have to achieve that milestone. Second question has to do with AT-587. You mentioned about the first-in-human study and the design.

I guess two parts. One is for this first in human study, what is the treatment duration that you intend to test? I guess in the real world setting, what do you expect the treatment duration to be? Thank you.

That is a great question. First, look, our goal is to have a regimen delivered to patients and prescriber, and with the attributes that we have and we continue to demonstrate through clinical trials and non-clinical studies as well, or clinical pharmacology studies as well. Our goal is a non-inferiority trial, as you know, within a 5% margin. When we talk about the real world, including the true intent to treat, you're right, it's around 90% or closer. If we take the same value in our phase II, we were about the same as the true intent to treat, as you know.

Look, let's see and, you know, we don't want to speculate what it's going to be. We are going to actually evaluate. We think we have sufficient power, definitely for the non-inferiority target. We'll see the superiority probably with the 2 trials, because that we will increase even the power when we combine the trial. There is actually an analysis that it is planned and that has been shared with the FDA, combining those 2 studies and evaluated for potential superiority. For the AT-587, it's a good question.

First, on phase I, it's going to be the MAD is going to be a 7-day, as standard phase I as we did with other indications. For the treatment duration, we foresee that we will start the proof of concept, which we believe we should be able to initiate by year-end, with a 12 weeks treatment duration. We are of the chronic toxicology studies ongoing right now. And we will have a readout after 3 months, sometimes in the fall. So definitely on time to open a CTA on the proof of concept. We will start very likely based on the phase I data that we will generate.

Probably, as you have seen from what we predicted, 600 milligram is a potential dose, QD or BID, we'll see. That would be a 12 weeks. Now, we will upfront do continue this chronic toxicology studies up to 6 months in rat and 9 months in monkey, because potentially we'll see, if we don't see a high SVR rate with 12 weeks, we can potentially move to 24 weeks. Treatment duration is not an issue in this patient population. As you know, they take lifelong treatment against organ rejection. Compliance should be very good. We have seen so far safety from a pre-clinical standpoint have been good.

We can have quite the flexibility in the phase I, as I have just indicated, related to a QD or BID regimen, whether 12 weeks or 24 weeks.

That's very helpful. Thank you.

Thank you. We have reached the end of the question and answer session. I'd like to turn the call back now to Jean-Pierre Sommadossi for closing remarks.

Thank you all for joining our 1st quarter 2026 earning conference call, and thank you for your continued support.

Thank you. This concludes today's conference. You may disconnect your lines at this time. Have a wonderful day.

Good afternoon, everyone, and welcome to the Atea Pharmaceuticals' Fourth Quarter 2025 Financial Results and Business Update Conference Call. [Operator Instructions] 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. Barnes, please proceed.

Great. Thank you, operator. Good afternoon, everyone, and welcome to Atea Pharmaceuticals' Fourth Quarter and Full Year 2025 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.ateapharma.com. With me today from Atea are our Chief Executive Officer and Founder; Dr. Jean-Pierre Sommadossi; Chief Development Officer, Dr. Janet Hammond; Chief Commercial Officer, John Vavricka; Chief Medical Officer; Dr. Arantxa Horga; and Chief Financial Officer and Executive Vice President of Legal, Andrea Corcoran, who will be available for the Q&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. 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.

Thank you, Jonae. Good afternoon, everyone, and thank you for joining us. I will begin on Slide 3. I am pleased to report that we have made substantial clinical progress in the last year, advancing our global Phase III program evaluating the regimen of bemnifosbuvir and ruzasvir for the treatment of HCV infections. Due to the rigorous execution of our two pivotal Phase III trials, C-FORWARD and C-BEYOND, we expect top line readout this year for both trials. We also presented several dataset reinforcing the potential best-in-class profile of our regimen at the EASL Congress in 2025 and the Liver Meeting 2025, the Annual Meeting of AASLD. Janet will discuss highlights from these presentations. We convened two panel discussions with key opinion leaders that underscore the need for a new optimized HCV regimen to address treatment paradigm shifts, including the test-and-treat model of care and how our regimen is uniquely positioned to address the current needs of patients and prescribers and expand the market in the U.S. In November, we announced the expansion of our antiviral hepatitis pipeline to address a major unmet medical need for immunocompromised patients living with chronic hepatitis E infection, a liver disease for which there is currently no approved therapy available. If left untreated, it can rapidly progress to cirrhosis within 3 to 5 years. In vitro and in vivo results presented last month at CROI 2026 and at the JPMorgan Healthcare Conference in January support our lead product candidate, AT-587 as a potential first-in-class inhibitor against HEV infection. I will review this exciting program later in the presentation. Moving to Slide 4. I'm pleased to report that our global Phase III HCV program is on track. In December, we completed enrollment for our North American trial, C-BEYOND, with over 880 patients, and we expect to complete enrolling C-FORWARD, our trial outside of North America, by midyear. We anticipate top line results for C-BEYOND midyear and for C-FORWARD by year-end. Following our selection of AT-587 as the lead product candidate in our HEV program, we initiated IND and CTA-enabling studies and anticipate initiating a first-in-human study midyear. Importantly, with $301.8 million of cash, cash equivalents and marketable securities as of December 31, 2025, we are in a strong financial position to execute and complete our Phase III HCV program and advance our new HEV development program. We anticipate our cash runway will extend through 2027. With that, I will now turn the call over to Janet to review the profile of our regimen.

Thanks, Jean-Pierre. Moving to Slide 6. Hepatitis C remains a significant global health care crisis with an increasing incidence of infections despite the availability of direct-acting antivirals for the past decade. Currently, in the United States, out of the reported 160,000 new chronic infections, only 85,000 patients are treated annually. In 2015, there were approximately 2.5 million people infected in the United States. Today, that number has nearly doubled to approximately 4 million. The unrelenting high rate of new chronic hepatitis C infections, which continues to outpace the number of patients being treated, underscores the need for a new differentiated and optimized therapy. In the map shown on the right, you can see that most countries worldwide, including the United States, are not on track to achieve the World Health Organization's goal of the elimination of hepatitis C by 2030. In fact, current estimates suggest we may not even achieve this goal by 2050. Let's not forget that hepatitis C is the primary cause of liver cancer in the United States, the incidence of which is projected to increase by over 50% within the next 5 years from approximately 850,000 cases in 2025 to 1.4 million people. On Slide 7, we are conducting the first global head-to-head active controlled Phase III trials in our program for hepatitis C, comparing our regimen against the current standard of care, sofosbuvir and velpatasvir, which are marketed as Epclusa. Results support our regimen as a potential best-in-class treatment option for patients infected with HCV with a differentiated profile featuring a highly potent combination with a short treatment duration, low risk for drug-drug interactions and convenience with no food effect. We continue to build out our dataset and recent results demonstrated a low risk for drug-drug interactions with proton pump inhibitors, which are taken by an estimated 35% of hepatitis C infected patients. Moving to Slide 8. We presented several datasets supporting the potential best-in-class profile of the regimen of bemnifosbuvir and ruzasvir last year at the EASL Congress and then at the Liver Meeting. Results from the Phase II study in 275 patients demonstrated the 8-week regimen of BEM-ruzasvir achieved 98% SVR12 in the per-protocol treatment-adherent population and a 95% SVR12 in the efficacy-evaluable population. Additional results demonstrated that the regimen has a high barrier to resistance. The regimen has a low risk for drug-drug interactions, including with proton pump inhibitors, H2 blockers and also standard HIV therapy. There is no need for dose adjustment of bemnifosbuvir in patients with hepatic or renal impairment. The regimen can be taken with or without food. In addition, recently generated data show that in addition to inhibiting HCV RNA replication through chain termination, bemnifosbuvir also inhibits assembly and secretion of new hepatitis C virions, further explaining its high antiviral potency. With that, I'll now turn the call over to Arantxa to provide an update on our Phase III program for hepatitis C. Arantxa?

Thank you, Janet. On Slide 10, C-BEYOND enrolled patients in the U.S. and Canada, and C-FORWARD is enrolling patients in 17 countries outside of North America. Combined, we expect to enroll more than 1,760 patients in our Phase III program. Both trials are open-label, randomized 1:1 against the active comparator and stratified by cirrhosis status, genotype and including patients co-infected with HIV. In patients without cirrhosis, treatment duration is 8 weeks with bemnifosbuvir-ruzasvir and 12 weeks with the standard of care. Patients with compensated cirrhosis receive 12 weeks of treatment with either regimen. The primary endpoint for both studies is sustained viral response or cure 24 weeks after treatment initiation. Slide 11 shows the geographic footprint of our global Phase III program with approximately 120 clinical sites in the U.S. and Canada for C-BEYOND, and another 120 clinical sites in 17 countries outside of North America for C-FORWARD. As J.P. mentioned earlier, C-BEYOND patient enrollment was completed in December with more than 180 patients, and we anticipate top line results midyear. C-FORWARD has a broader global geographic and genotypic footprint, and we expect to complete enrollment midyear and to report top line results by year-end. On Slide 12, let's review the Phase III endpoints, patient population and data analysis for our global Phase III program. In C-BEYOND, the primary endpoint will be analyzed in a modified intent-to-treat population as preferred by the U.S. FDA. The analysis will include patients that have been randomized and dosed regardless of drug adherence or lost to follow-up. The statistical analysis will be based on an imputation model with success or failure depending on PCR value, whether negative or not, prior to patient treatment discontinuation. A key secondary endpoint will include the SVR rate of the per-protocol population. In C-FORWARD, the per-protocol population will be analyzed as the primary endpoint as preferred by the EMA. And the SVR rate will only include patients who are at least 80% adherent as measured by pill count and have an SVR assessment at week 24. A key secondary endpoint will include the SVR rate for a modified intent-to-treat population. The same methods for assessing non-inferiority will be conducted in both Phase III studies on both patient populations. The Phase III studies are powered 90% with 5% non-inferiority margin with expected rates approximating 95% in an mITT population. Using these two approaches in a post-hoc analysis of the Phase II results, the SVR rate was 95% in an mITT population and 98% in the per-protocol population. I will now hand the call over to John Vavricka, our Chief Commercial Officer. John?

Thank you, Arantxa. Moving on to Slide 14. As discussed earlier in the call, the rate of newly reported HCV infections in the U.S. is outpacing treatment. Out of approximately 160,000 new HCV infections, only 85,000 patients are treated annually for a total of approximately $1.3 billion in net sales in the U.S. We have consistently heard from health care providers that the test-and-treat model of care, which allows for HCV testing, diagnosis and treatment at the point of care can reduce the barriers to prompt initiation of therapy that exists today. The test-and-treat model of care has gained broad support, including by the CDC and continues to gain momentum through recent bipartisan efforts to advance HCV elimination in the U.S. Key opinion leaders also [ certainly ] can play a critical role in HCV elimination efforts and agree that a treatment optimized to work seamlessly with this model is still needed. Slide 15. While we are advancing our global Phase III trials, we are also preparing for a commercial product launch. Our commercial package will include a blister card for convenience and adherence with a simple 4-week dosing package. The drug product has a low cost of goods relative to net price. And based on our current projections, we anticipate achieving profitability relatively shortly post-launch. From a commercial standpoint, the U.S. HCV prescriber base is highly concentrated with approximately 6,000 prescribers writing 80% of the DAA prescriptions, making it optimal for efficient commercialization using a focused specialty sales force. We anticipate a commercial sales force of around 75 people, which includes the sales team and medical science liaisons. Let's move on to Slide 16. Using our Phase II results, IQVIA conducted an independent quantitative market research study with 153 U.S. high prescribers. These physicians indicated that they would likely prescribe the BEM-RZR regimen to approximately half of their patients, and the results were similar for all patients regardless of their cirrhosis status. Our market research also showed that U.S. payers responded favorably about the potential to include BEM-RZR in the formulary based on the regimen's profile. I'll now hand the call back to Jean-Pierre to review the HEV program.

Thank you, John. Let's now move to Slide 18. Hepatitis E virus or HEV is in an acute and a chronic liver disease. In developing countries, genotype 1 and 2 are most prevalent and the virus is transmitted primarily through contaminated water and mostly cause epidemics of acute self-limiting viral hepatitis. In developed countries, genotype 3 is predominantly transmitted primarily through contaminated food such as undercooked meat. This can cause chronic hepatitis in immunocompromised patients and can progress to cirrhosis within 3 to 5 years, which is much far more aggressive than what is seen with hepatitis C or hepatitis B. With no approved therapies for HEV, there is a significant unmet need for a treatment option. Moving to Slide 19. In recent years, with the increasing number of patients who are immunocompromised, which include solid organ transplant recipients, hematopoietic stem cell transplant recipients, patients with hematologic malignancies such as multiple myeloma, there have been a growing incidence of chronic HEV infection in U.S. and Europe. In the absence of any approved therapies for HEV, the standard of care includes reducing immunosuppression and/or ribavirin administration, which both presents challenges. On Slide 20, each year in the U.S. and Europe, about 3% of approximately 450,000 patients who have these underlying medical conditions are at risk to develop chronic HEV. We estimate that the unmet need for this patient population represents a market opportunity between $750 million to $1 billion per year. And obviously, this will follow on orphan designation. On Slide 21, let's now review data supporting the selection of AT-587, our lead product candidate, a potential first-in-class direct-acting antiviral treatment option for chronic HEV. As you see on this slide, in vitro and in vivo activity of bemnifosbuvir was shown against hepatitis C. However, the more potent in vitro activity of AT-587, combined with the positive PK data, which we'll discuss next, led us to select AT-587 as a lead product candidate. The in vitro data on this slide shows the potent nanomolar antiviral activity of AT-587 against HEV genotype 3 and to remain also active against clinical ribavirin resistance-associated substitutions or RAS. As noted earlier, ribavirin is off-label for the treatment -- is used off-label for the treatment of HEV. On Slide 22, we observed that the in vivo single-dose PK studies in rats and monkeys, AT-587 achieved high plasma concentration of the active triphosphate metabolite surrogate, which were comparable to those obtained with bemnifosbuvir. On Slide 23, of particular importance, we also demonstrated that AT-587 efficiently converted to its active triphosphate metabolite in human hepatocytes, which is the site of viral replication in HEV infection. To date, AT-587 has a clean preclinical safety profile, positioning this product candidate as a first-in-class direct-acting antiviral for chronic HEV. I will now turn the call over to Andrea to discuss Atea financials.

Thanks, Jean-Pierre. As Jonae mentioned in her introductory remarks, earlier today, we issued a press release containing our financial results for the fourth quarter and full year 2025. The statement of operations and balance sheet are on Slides 25 and 26. We are pleased to report that our cash and investments were $301.8 million at December 31, 2025. The funds expended in 2025 were principally directed to the advancement of our HCV Phase III program, evaluating the combination regimen of bemnifosbuvir and ruzasvir and to discovery efforts leading to the nomination in January 2026 of AT-587 as the lead product candidate for the treatment of HEV. In 2025, we also returned $25 million to our stockholders through a share repurchase program. Each of these investments and use of funds reflects our steadfast commitment to drive value for our stockholders. For R&D expenses quarter-over-quarter and year-over-year, there was an increase in 2025 compared to 2024. The net increase in 2025 was principally driven by an increase in external spend for our HCV Phase III clinical development, offset by a decrease in 2025 in external spend for our COVID-19 clinical development and lower internal expenses, primarily related to a decrease in stock-based compensation expense and lower payroll and payroll-related expenses. For G&A expenses quarter-over-quarter and year-over-year, expenses decreased. The net decrease was primarily related to lower stock-based compensation expense, partially offset by increased professional fees. For 2026, we intend to maintain our rigorous financial discipline while remaining laser-focused on execution and value-creating advancement of our HCV and HEV product candidates. As we complete our Phase III clinical trials, prepare to submit our regulatory filings and engage in prelaunch activities, including the manufacturing of commercial launch supply, the substantial majority of our spending in 2026 will be focused on the advancement of our HCV program. With the resources in hand as of the end of the year, we expect to realize value-creating milestones for both programs and project our cash runway to extend through 2027. I'll now hand the call back to Jean-Pierre for closing remarks.

Thank you, Andrea. On Slide 27, in closing, 2026 will be a pivotal year for Atea. We are on track to deliver top line Phase III results from C-BEYOND midyear. These results will be followed by the top line results from C-FORWARD by the end of this year. We believe that the target profile of our regimen featuring high efficacy, short treatment duration, low risk of drug-drug interaction, convenience with no food effect will uniquely position us to address the need of today's patients and seamlessly fit in the test-and-treat model of care, which has the potential to bring us closer to the ultimate goal of HCV eradication. Our HEV program represent a strategic expansion of our antiviral pipeline and address a major unmet need in a highly vulnerable patient population for which there is no approved treatment available. We anticipate initiating a first-in-human study midyear with a proof of concept by the end of the year and possible to advance to a Phase II/III trial in the second half of 2027. With that, I will turn the call back over to the operator.

[Operator Instructions] The first question will come from Maxwell Skor with Morgan Stanley.

This is Selena on for Max. Having achieved your enrollment target for the cirrhotic population for C-BEYOND, does that increase your confidence in hitting your target in C-FORWARD?

Arantxa?

We are going to achieve our target overall for the program, both in C-BEYOND and C-FORWARD. The cirrhotic enrollment has not been an issue.

The next question will come from Jonathan Miller with Evercore ISI.

As we look forward to a commercial launch in HCV, I guess I'll focus there. Can you talk a little bit about how the commercial landscape is currently organized in terms of contracting? Are there centralized groups that you're going to have to convince to switch over from legacy systems? How is pricing in the commercial universe currently going to evolve as we've seen the legacy regimens get put under significant pricing pressure. So can you talk a little bit about how the commercial landscape has evolved over the past 6, 9 months and how well you're positioned to deal with those changes?

Great question, Jon. John?

Sure. So as you know, that the market for -- the distribution market for specialty -- for DAAs is a specialty market. And there are three segments pretty much, commercial, Medicare and Medicaid. All of those current distribution pathways are known and are fully utilized. And we're currently looking at all of those relative to the three segments as well as relative to the payers. So it's a known quantity where we will have to be. We actually have conducted preliminary research with the payers and obviously seeing the profile, it is of interest to them. And it was stated that they would be eager to include it in formulary. As far as for pricing goes, the pricing, it's relatively stable. Year-over-year, Mavyret pricing went up a little bit, but Epclusa pricing -- net pricing did go down. But overall, for the past at least 2 or 3 years, the pricing has been -- the relative overall net pricing has been relatively stable and their market shares are getting pretty close to a 50-50 with the favoring Epclusa. Does that answer your question?

Yes, it does.

The next question will come from Andy Hsieh with William Blair.

So looking at the primary endpoint of C-BEYOND based on the -- modified to intent-to-treat population, am I thinking about this correctly that based on this analysis plan, you can actually really expand the effect size because you can basically magnify a regimen that actually can have flexibility into missing doses and given the more potency profile compared to the standard of care. So that's part number one. And part number two is in a scenario where you can actually show material clinical benefit over the standard of care, say, maybe with a statistical perspective, John, based on your market analysis, how would that change some of the physician response in terms of their excitement or potential market uptake?

Good questions, Andy. Arantxa, do you want to try the first one?

Yes. Andy, so the mITT, as you know, is everybody that gets a dose. So there will be a range there from people that will get 1 dose or maybe 5 days of dosing to people who will be almost done with the full picture, so with all the doses. So I think it will be interesting to see how it pans out, what's the minimum, I guess. But right now, we're really aiming for an 8-week regimen. We can do sub-analysis in the future.

John?

Yes. We're actually very excited because when we look at the market research that has been done just with the Phase II data, bearing in mind that these physicians had 10 years' experience with two DAAs, and showing them a profile and which as we talked about, the short duration, low likelihood of drug-drug interactions and the convenience of with or without food, just seeing that profile for the first time, they saw it being used in approximately 50% of their patients regardless of their cirrhosis status. So the profile right now stands very, very well. So your question about if there was some kind of a more favorable response in terms of BEM-RZR, obviously, that would play into their likelihood to prescribe BEM-RZR. But we're also very conscious that we play in the specialty arena. And in that specialty arena, obviously, the distribution of market share tends to balance itself out to make sure that the market is preserved over time.

Just to add, Andy, it's clear from the KOL and the prescribers that #1 key important feature is the treatment duration. So treatment duration definitely will be on the shortest with Mavyret. But then after when you evaluate all the, I would say, complex aspects with patients with polymedication, we feel that the prescriber will really highly favor our regimen. And then we'll see -- we'll have to wait, the clinical data in terms of all the type of side effects with fatigue and nausea and headache that have been reported. So let's not forget that this is the first head-to-head. There is a lot of world-type studies. But as a controlled randomized clinical study, this is the first one. And let's see what we are going to learn.

Great. And maybe a quick housekeeping item. Just from an R&D perspective, it seems like there is a one-time Merck license agreement. Can you talk about that just so we have a better sense of kind of going forward, what the...

Okay. Sure. Andrea?

So yes, Andy, we have in-licensed ruzasvir, which is the combination product with bemnifosbuvir in the HCV product candidate. We are paying milestones, and we will pay royalties to Merck on successful commercialization. The next milestone will be due when we submit the NDA and the NDA is approved. And we believe that's in 2027.

This concludes our question-and-answer session. I would like to turn the conference back over to Jean-Pierre Sommadossi for any closing remarks.

Thank you all for joining our fourth quarter 2025 and full year earnings conference call, and thank you for your continued support.

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.