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Transcript Summary

Atea Pharmaceuticals reported significant progress in its dual-track clinical strategy during its Q1 2026 earnings call. The company is nearing pivotal data readouts for its Phase III Hepatitis C (HCV) program, featuring the combination of bemnifosbuvir and ruzasvir. Top-line results from the North American C-BEYOND trial are expected mid-2026, while the global C-FORWARD trial is on track for a year-end readout. Management highlighted the regimen's competitive profile, emphasizing its low risk for drug-drug interactions and short treatment duration. Simultaneously, Atea is expanding into the Hepatitis E (HEV) market with AT-587, targeting immunocompromised patients who lack approved treatment options. First-in-human HEV trials are scheduled for mid-2026, with proof-of-concept anticipated by year-end. Financially, Atea maintains a robust balance sheet with $256 million in cash and investments, providing a runway through 2027. This liquidity supports the transition toward commercialization, where the company plans a lean, specialty sales force of 75 people to target the concentrated U.S. HCV prescriber base. The call concluded with management expressing high confidence in their ability to address major unmet needs in viral hepatitis and deliver value-creating milestones throughout 2026.

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Full Earnings Call Transcript — Q1 • 2026-05-13

Operator: Ladies and gentlemen, thank you for standing by. Welcome to Atea Pharmaceuticals First Quarter 2026 Earnings Conference Call. [Operator Instructions] I will now turn it over to the Atea's management team. Please go ahead.
Jonae Barnes: 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 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 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.
Jean-Pierre Sommadossi: Thank you, Jonae. Good afternoon, everyone, and thank you for joining us. I will begin on Slide 3. With 2 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 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 2 important Phase III milestones. We expect top line data from C-BEYOND in midyear, 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 C 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 midyear. 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, cash equivalents and marketable securities as of March 31, 2026, 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 remaining through 2027. With that, I will now turn the call over to Janet to review the profile of our regimen.
Janet Hammond: 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, 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. We continue to add to our data set and recent results demonstrate a low risk for drug-drug interactions with proton pump inhibitors, which are taken by an 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 supports 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?
Maria Horga: Thank you, Janet. Moving ahead to Slide 7. As a reminder, 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 and genotype, including patients co-infected with HIV. In patients with cirrhosis, treatment duration is 8 weeks with bemnifosbuvir and 12 weeks with the standard of care. Patients with compensated cirrhosis received 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 III 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 midyear. C-FORWARD has a broader global geographic and genotypic footprint, and we expect to complete enrollment midyear and to report top line results around year-end. As J.P. 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 midyear. On Slide 9, let's review the Phase III endpoints, patient population and data analyses 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 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 be the SVR rate in the per-protocol population. In C-FORWARD, the per-protocol population will be analyzed as the primary endpoint as preserved 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 method for assessing noninferiority will be conducted in both Phase III studies and in both patient populations. The Phase III studies are powered 90% with 5% noninferiority margin with expected rates above 95% in a modified intent to treat or mITT population. Using these 2 approaches in our post-hoc analyses of the Phase II results, the SVR rate was 95% in [indiscernible] and 98% in the per-protocol population. I will now hand the call over to John Vavricka, our Chief Commercial Officer. John?
John Vavricka: Thank you, Arantxa. I'll begin on Slide 11. HCV 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 U.S., out of the 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 health care 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, and 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 parity 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 BEM/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 inclusive skewing more heavily towards Medicare by 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 BEM/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. The prescriber base is highly concentrated, roughly 7,800 physicians write about 80% of all DAA prescriptions, but 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, BEM/RZR enters the 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 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 of profitability following NDA approval. I will now hand the call back to Jean-Pierre to review the HEV program.
Jean-Pierre Sommadossi: 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. And as you may know, this is far more aggressive than what's occurred 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 have been a growing incidence of chronic hepatitis C infection in 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 U.S. and Europe, 3% of approximately 450,000 patients who have this underlying medical condition are at risk to develop chronic hepatitis C. The unmet need for this patient population potentially represent a market opportunity between $750 million to $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 demonstrates the greatest potency. And importantly, this antiviral activity has also been confirmed in primary human hepatocytes, the target organ for hepatitis E replications. 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, to date, 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 E infections. On Slide 23, [ the emerging ] PK data in nonhuman 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 objective of evaluating safety, tolerability and pharmacokinetics. It's a randomized, double-blind, placebo-controlled design with sequential dose escalation and an embedded food 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 dose levels as data emerge. I will now turn the call over to Andrea to discuss Atea financials.
Andrea Corcoran: Thank you, Jean-Pierre. As Janet 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 advancement of -- and 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 '26 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 prelaunch activities, including the manufacturing of commercial launch supply. A 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, and we project our cash runway to extend through 2027. I'll now hand the call back to Jean-Pierre for closing remarks.
Jean-Pierre Sommadossi: 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 results 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 regimen, high 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 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 medication in the United States 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 a proof-of-concept study around year-end. With that, I will turn the call back over to the operator.
Operator: [Operator Instructions] Our first question is from Jonathan Miller with Evercore.
Jonathan Miller: 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, so, a. And then second, when we think about commercial launch cadence and potential there, assuming the Phase IIIs 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 drug that chooses.
Jean-Pierre Sommadossi: Thank you, Jon. Okay. I will address the first question. The first question, we will release as data with the C-BEYOND, the primary endpoint and the key secondary efficacy endpoint. So the SVR at week 24 after initiation of treatment in the modified intent-to-treat 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?
John Vavricka: Sure. So Jon, thank you for the question. So currently, our launch preparation are currently underway, and that includes the analysis and evaluation of the marketplace and understanding currently where the business segments are coming from, where likely future growth coming from and also looking at where we will focus our activities. And that would be including across the 3 segments from a commercial perspective of payers in terms of who we want to target and what their formulary status is right now and all those associated time lines as well as preparations for Medicaid and Medicare areas. And the activities we will pull -- start executing them upon the data of our Phase III trials. And part of the question that you asked in terms of understanding what those time lines are and so forth, we will be evaluating all of that as we put into our penetration segments for the market.
Operator: Our next question is from Maxwell Skor with Morgan Stanley.
Selena Zhang: This is Selena on for Max. 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?
Jean-Pierre Sommadossi: Arantxa do you want to address that question?
Maria Horga: Go ahead.
Selena Zhang: Yes. So 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 payer response?
Maria Horga: So I think we see things along the same trends that we saw in Phase II, which is great efficacy with low potential for drug-drug interaction, no food effect, et cetera. So data consistent with Phase II, which is what we see -- always see 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.
John Vavricka: No, I think I'm fine. Obviously, we used the Phase II data, and that data was very well received. And the only thing I'll tell you is that the payers and others are also very much interested in having a head-to-head trial because it's the first time. And it was something that's very intriguing and important to them as well. And it plays into the previous question about being ready for launch readiness. And one of those factors when you talk to the payers also is the head-to-head trial is very helpful to them.
Operator: Our next question comes from Andy Hsieh with William Blair.
Tsan-Yu Hsieh: First one, it has to do with C-BEYOND. So looking at the modified intent-to-treat population analysis plan, I think you basically calculated SVR12 of 95% based on the Phase II study. Looking across the landscape, I believe Gilead published some of the noncompliant SVR12 rates before, and it's in the low 90s depending on the trials that you're looking at. So I'm curious about your thinking in terms of a superiority claim based on that delta. So just maybe commenting on the powering and sample size to see what level of confidence you have to achieve that milestone. Second question has to do with 587. You mentioned about the first-in-human study and the design. I guess, 2 parts. One is for this first-in-human study, what is the treatment duration that you intend to test? And then I guess, in the real-world setting, what do you expect the treatment duration to be?
Jean-Pierre Sommadossi: Andy, it's a great question. First, look, our goal is to have our regimen delivered to patients and prescriber and with the attributes that we have and we continue to demonstrate through clinical trials and nonclinical studies as well or clinical pharmacology studies as well. And so our goal is a noninferiority trial, as you know, within 5% margin. When we talk about the real world, including a 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 a true intent-to-treat, as you know. So look, let's see -- 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 noninferiority target. And we'll see the superiority probably with the 2 trials because that we will increase even the power when we combine the trial. And there is actually an analysis that it is planned and that has been shared with the FDA combining this 2 study and evaluated for potential superiority. For the AT-587, it's a good question. First and then Phase I 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 the chronic tox -- toxicology studies ongoing right now, and we will have [ p-ANCAs ] 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 the -- from what we predicted, 600-milligram is a potential dose, QD or BID, we'll see. And that would be at 12 weeks. Now we will upfront to 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. So compliance should be very good. And we have seen so far, safety from a preclinical standpoint have been good. And 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.
Operator: We have reached the end of the question-and-answer session. I would like to turn the call back now to Jean-Pierre Sommadossi for closing remarks.
Jean-Pierre Sommadossi: Thank you all for joining our first quarter 2026 earnings conference call, and thank you for your continued support.
Operator: Thank you. This concludes today's conference. You may disconnect your lines at this time. Have a wonderful day.