AVIR

Image source: The Motley Fool. Wednesday, Aug. 12, 2026 at 4:30 p.m. ET Senior Vice President of Investor Relations and Corporate Communications - Jonae R. Barnes Chief Executive Officer and Founder - Jean-Pierre Sommadossi Chief Medical Officer - Maria Arantxa Horga Chief Development Officer - Janet J. Hammond Chief Commercial Officer - John F. Vavricka Chief Financial Officer and Executive Vice President of Legal - Andrea J. Corcoran Operator: Good afternoon, everyone, and welcome to the Atea Pharmaceuticals Second Quarter 26 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 for your questions. I would now like to turn the call over to Jonae R. Barnes, senior vice president of investor relations and corporate communications at Atea Pharmaceuticals. Miss Barnes, please proceed. Jonae R. Barnes: Thank you, operator. Good afternoon, everyone, and welcome to Atea Pharmaceuticals second quarter 26 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 will be reviewing today by going to the Investors section of our website at ir.atayapharma.com. With me from Atea are our chief executive officer and founder, Dr. Jean-Pierre Sommadossi chief development officer, Dr. Janet J. Hammond chief commercial officer, John F. Vavricka chief medical officer, Dr. Arantxa Horga; chief financial officer and executive vice president of legal, Andrea J. 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 will 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. The positive top line results from CBEYOND our phase 3 trial evaluating the combination of BAM versus for the treatment of hepatitis C in North America represent a significant milestone for Atea. And for the millions of people living with hepatitis C, who need a shorter simpler path to cure. We were very pleased that CBEYOND met both its primary and secondary endpoints with bemrusasvir demonstrating statistical non inferiority to Epclusa. The current standard of care. Importantly, this was the first successful phase 3 trial in the global head to head HCV program. Achieved in the real world patient population that was polymedicated psychiatrically complex, substance abuse effective, and adverse challenge. These results reinforce the need for best in class profile designed for the broad and complex hepatitis C population clinicians treat today. Arantxa will review in detail the results of the trial. Threefold, our second phase 3 trial. Being conducted outside North America is fully enrolled, with more than 880 patients and we remain on track to report top line results in early Q1 2027. We believe that the c forward dataset will provide important complementary efficacy data across a broader range of genotypes and strengthen the pangenotypic regulatory package In July, we also initiated our first in human Phase 1 clinical trial of 87 our potential first in class direct acting antiviral for chronic hepatitis e. A serious disease with no approved therapy today. This milestone reflects the continued advancement of our oral direct-acting antiviral pipeline. We remain in the solid financial position with $219.5 million in cash and marketable securities as of June 30, 2026. With our cash runway, anticipated through 2027. I will now hand the call over to Arantxa, our chief medical officer, to review our phase 3 program. Maria Arantxa Horga: Thank you, Jean-Pierre. Good afternoon, everyone. Moving to Slide 5, C-BEYOND was a randomized, active-control, non-inferiority trial against sofosbuvirvelpatasvir marketed as Epclusa. A standard of care regimen. The trial involved patients with chronic HCV at approximately 120 clinical sites in The US and Canada. Including patients coinfected with HIV and patients across the HCV genotypes that predominate in North America. Patients without cirrhosis received bemrusasvir for 8 weeks or sofosbuvir/velpatasvir for 12 weeks. Patients with compensated cirrhosis will receive 12 weeks of treatment with either regimen. On slide 6, let's now review the CBEYOND endpoints and patient populations. The primary efficacy endpoint is SVR or cure, at week 24 assessing the modified intent to treat or MIPT population, which was agreed upon with the FDA. This population includes all patients who received at least 1 dose of the regimen, including those who discontinued early, were not compliant, or were lost to follow-up. The trial is powered at 90% with a 5% non-inferiority margin. C-BEYOND is the anchor trial for the US NDA submission. Moving to slide 7, you can see that the baseline characteristics of the patients in C-BEYOND were very well balanced across the 2 arms. Including age, sex, BMI, race, and ethnicity, cirrhosis status, viral load, and HIV co infection. On slide 8, C-BEYOND enrolled the HCV population clinicians are treating in North America today. Which looks meaningfully different from the population studied a decade ago. In our trial, more than half of the patients reported injection drug use as the route of HCV transmission. Approximately 89% were taking concomitant medications. 2-thirds had a psychiatric disorder, and over 10% prematurely discontinued treatment were lost to follow-up or were not adherent to the protocol. Current standard of care regimens have challenges where it matters most. A moderate protease inhibitor containing regimen carries DDI limitations that restrict or complicate use in many of these patients while Epclusa requires 12 weeks of treatment. In our market research, only 6% of 157 high prescribing US physicians reported no unmet need with physicians continuing to cite key priorities such as shorter duration, high efficacy, and fewer contraindications. Let's now review the Phase 3 results on Slide 9. In the primary endpoint MITT population, Bemrusasvir achieved a 93.9% SVR rate compared with 94.8% for sofosbuvir/velpatasvir at week 24. Encompassing SVR 12 the accepted definition of cure for HCV. These results met the primary endpoint of statistical non inferiority within the prespecified 5% margin. Bemrusasvir delivered cure rates comparable to the standard of care while offering an 8-week regimen for non cirrhotic patients. Compared to 12 weeks for sofosbuvir/velpatasvir. On Slide 10, in the non-cirrhotic MITT population, bemrusasvir achieved a 93.5% SVR rate with 8 weeks of treatment compared with 94.6% for sofosbuvir/velpatasvir with 12 weeks of treatment. In patients with compensated cirrhosis, both arms achieved a 95.4% SVR rate, with 12 weeks of treatment. Patient subpopulations are not powered for statistical analysis. On slide 11, is the safety summary. Overall, adverse events were comparable between the 2 treatment arms. Most treatment emergent adverse events were mild to moderate and balanced between treatment arms. There were no serious adverse events due to the study drug, and while there were no deaths in the bemrusasvir arm, 3 deaths in the sofosbuvir/velpatasvir arm were observed but not related to the study drug. Similarly, there were no early treatment discontinuations related to the study drugs. Moving to slide 12, real world adherence and discontinuation of treatment with loss to follow-up remains a major barrier in HCV treatment today. And helps explain why current SVR rates with approved therapies can fall below the rates reported 10 years ago in the original pivotal studies. Indeed, as you can see more recent studies, the intent-to-treat SVR rates fall below the rates reflected in labels established a decade ago. Including rates as low as 74%. Among people who injected drugs with rates consistently in the low 90s. Slide 13 summarizes the top line results for C-BEYOND. The trial met its primary and secondary endpoint, with bemnifosbuvir/ruzasvir demonstrating consistent SVR rates regardless of cirrhosis status and robust performance across genotypes. Virologic failure rates were low and comparable across treatment arms. Bemrusasvir was generally safe and well tolerated with a safety profile comparable to sofosbuvir/velpatasvir. On Slide 14, is the patient populations and analysis for C FORWARD our second phase 3 trial, being conducted outside of North America to enable a broad pangenotypic label. It is fully enrolled, and enriched for genotypes 1b, 3, 4, 5, and 6 using the same non inferiority methodology and the same powering assumptions. Together, the 2 phase 3 studies will form a comprehensive global data package for regulators worldwide. I will now hand the call over to Janet our Chief Development Officer. Janet J. Hammond: Thank you, Arantxa. Good afternoon, everyone. Moving on to Slide 16, BEM-ruzasvir is a next generation pangenotypic once daily, fixed-dose regimen. Bemnifosbuvir is the most potent nucleotide we are aware of. Being approximately tenfold more active than sofosbuvir in vitro. And is a picomolar potency pangenotypic NS5B inhibitor. Together, they have been administered to thousands of individuals with generally favorable safety and tolerability. Compared to Epclusa and Mavyret, bemnifosbuvir/ruzasvir is the only regimen positioned to offer the full combination of short 8 week duration for noncirrhotic patients protease inhibitor free composition, low potential for drug interactions, and no food effect. That combination is what defines a potential best in class profile. On slide 17, the drug interaction profile is a key differentiator for bemrusasvir. Roughly 80% to 90% of hepatitis c patients in The United States take concomitant medication. And prescribers strongly prefer therapies that are simple to prescribe. Across the classes of oral contraceptives, protease inhibitors, and integrase inhibitor HIV regimens, statins, immunosuppressants, digoxin, and proton pump inhibitors, and other acid reducing therapies, bemrusasvir is expected to be broadly compatible where competitors carry contraindications or require dose modification. Fewer drug interactions, strict and fewer specialist referrals. Fewer treatment delays, and more patients actually starting and completing therapy. Today's treatment challenge is less about efficacy and more about treatment duration, adherence, drug interactions, and access. Based on the potential profile of BEM-ruzasvir, we believe our regimen is well positioned to address these barriers and expand the number of patients successfully treated. I will now turn the call over to John F. Vavricka, our Chief Commercial Officer. John F. Vavricka: Thank you, Janet. Let's move on to Slide 19. I want to address what we believe is a widely misunderstood dynamic in the market. Wall Street often looks at revenue trends for approved HCV therapies and concludes that this is a declining market. However, the prevalence and treatment data tell a different story. Newly diagnosed patients with HCV infections continue to outpace patients treated annually. And that gap is widening In 2025, only around 50 percent of those newly infected patients were treated. The result is a growing HCV infected population moving towards 4 million people in The United States. Which is an expanding addressable market. The test and treat model of care is emerging as a reality. And will serve as a critical lever to close the gap of untreated patients. It will enable seamless rapid diagnosis and treatment initiation at the same point of care visit, reduce barriers for prescribing, and drastically reduce patient attrition even before treatment begins. This model has broad bipartisan support and is gaining momentum as a pathway towards HCV eradication in The United States. We believe our regimen's profile is optimal for this model of care. Let's move on to slide 20. The current HCV market dynamics create a clear opportunity for BEM/RZR. Short duration regimens continue to gain share, and prescribing is increasingly driven by polypharmacy and comorbidities. New infections keep outpacing treatment, and there is a decrease in commercial efforts by competitors. Each of these trends plays directly to the strength of BEM/RZR. We believe a potential best in class profile can expand treatment eligibility and improve treatment completion for patients whose medications, comorbidities, and life circumstances have historically limited access and adherence. In addition, there is a market growth potential with a simplified therapy and a focused commercialization. Moving on to slide 21. Our market research supports strong uptake of BEM/RZR. Among high volume DAA prescribers 76% said they would be extremely likely to prescribe BEM/RZR. And the research predicts roughly half of both non cirrhotic and compensated cirrhotics would receive BEM/RZR relative to Epclusa and Mavyret. On slide 22, we believe BEM/RZR is uniquely positioned to capture untreated patients and grow the market. Not simply to compete for existing share. Currently, only about half of diagnosed patients in The US are treated annually, leaving roughly 75 thousand untreated new infections last year on top of the already large prevalent pool of patients. In 2025, U. S. Net sales were $1.3 billion, representing 50% of the global net sales of $2.6 billion With its differentiated profile, BEM/RZR is uniquely positioned to expand the market potentially up to $2.5 billion annually in The United States. Slide 23. Taken together, we see peak annual US net revenue potential. In excess of $700 million that is anchored on a widening gap between infections and cures. Up to 4 million infected, and the increasing number of untreated people in The United States as a total addressable market. The pricing is expected to be in line with existing branded DAA market and DAA regimens. In closing, on slide 24, we continue to advance our commercial readiness activities across all key areas. The HCV prescriber base is highly concentrated with approximately 7.8 thousand physicians writing roughly 80% of all DAA prescriptions in The US. We can reach the vast majority of this market with a focus specialty sales force of approximately 75 to 100 Including sales representatives, sales managers, and medical science liaisons. All components and processes for large scale manufacturing are in place. Commercial drug supply is already underway with low cost of goods relative to the expected net price. And our 4-week dosing blister card packaging supports patient convenience and adherence. We believe these factors position us for a short time to profitability following a launch. I will now turn the call back to Janet to review the hepatitis B program. Janet J. Hammond: Thank you, John. On slide 26, In July, we initiated our first in human Phase 1 clinical trial of AT-587. The study is being conducted in healthy volunteers with the primary objectives of evaluating safety, tolerability, and pharmacokinetics. It is a randomized double blind placebo controlled design with sequential dose escalation and an embedded food effect assessment. The study includes both single ascending and multiple ascending dose phases, providing flexibility to refine dose levels as data emerge and with dose progression informed by real time safety and PK review. We have recently completed the first cohort and are moving forward to the next cohort. Hepatitis e has no approved therapy. So this is a potential first in class opportunity. That provides a meaningful pipeline program beyond hepatitis c. I am going to turn the call over now to Andrea Corcoran, our chief financial officer, to discuss Atea's financials. Andrea J. Corcoran: Thanks, Janet. As Jonae mentioned in her introductory remarks, earlier today we issued a press release containing our financial results for the second quarter of 26. The statement of operations and balance sheet can be found on Slides 28 and 29. We are pleased to report that our cash and investments balance was $220 million at June 30, 2026. The funds we expended in the second quarter were principally directed to the advancement of our HCV Phase III clinical trials CBEYOND and C FORWARD, and to a lesser extent to the completion of clinical trial startup activities for the first in human study of AT-587, which Janet just described is our product candidate for the treatment of HEV. As we have noted recently, milestone events in each program have been realized with the announcement of top positive top line results in CPEYOND, the completion of enrollment in SEEP FORWARD, and the initiation of the first in human clinical study of AT 27. In the first 6 months of 2026, our R&D expenses increased compared to the prior year, principally driven by higher external spend related to the HCV Phase III program and incremental HEV preclinical and clinical trial start up activities. These incremental expenses were partially offset by lower internal expenses, primarily due to decreases in stock based compensation and payroll related costs. With respect to G&A, there was a decrease in the first 6 months of 2026 compared to the prior year, due principally to lower salaries and lower wages. As well as lower stock based compensation. During the second half of 26, we intend to maintain our rigorous financial discipline while remaining laser focused on and value creating advancement of our HEV and HCV product candidates. As we complete SEE FORWARD, prepare to submit our regulatory filings, and engage in prelaunch activities, the substantial majority of our spending will remain focused on the advancement of our hepatitis C program. With the resources in hand at the end of June, we expect to realize these value creating milestones for both programs and we project our cash runway to extend through 2027. I will now hand the call back to Jean-Pierre for closing remarks. Jean-Pierre Sommadossi: Thank you, Andrea. In closing, on Slide 30, our milestones are clear and all near term. We completed patient enrollment for C-FORWARD in June, and top line results are expected in early Q1 27. Pending positive results from C-FORWARD, our NDA submission is anticipated in the second quarter. Of 27. Operator: In parallel, Ladies and gentlemen, please remain on the line. We are experiencing a technical difficulty. Once again, please remain on the line. Experiencing a technical difficulty. Analyst: Hello? Jean-Pierre Sommadossi: Thank you. Operator: JP, you may continue. Jean-Pierre Sommadossi: My apologies. I was disconnected. So in parallel, our hepatitis e program is progressing very well. And advancing toward proof of concept in 2027. We believe that BEM-ruzasvir's potential best in class profile including high efficacy, short treatment duration, a low risk of drug interactions, and no food effect position us to meaningfully contribute to the goal of HCV eradication in The US and globally. Based on our projection, we expect a short time to profitability after the anticipated mid 28 launch. We look forward to keeping you updated on our progress. And with that, I will now turn the call back over to the operator. Operator: Thank you. We will now be conducting a question-and-answer session. If you would like to ask a question, please press 1 on your telephone keypad. A confirmation tone will indicate that your line is in the question queue. You may press 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the number keys. 1 moment, please, while we poll for questions. Our first question comes from Andy Hsieh with William Blair. Please go ahead. Andy Hsieh: Great. Thanks for taking our questions, and congratulations on the big milestone for the company. So my first question has to do with labeling. I think, JP, you mentioned about the new mechanism of action. I am curious, with the assembly disruption mechanism, how do you get that into that into the label? that is number 1. and number 2, it has to do with the test and treat model. I think, John, you mentioned about that. you would also mentioned about the 1-month blister pack. Based on some of the conversations with KOLs, they really like to see a kind of test and treat model On top of that, you basically give all the drugs in 1 setting. And I am just wondering what steps do you have to take to really reach that goal. Thank you so much. Jean-Pierre Sommadossi: Okay. First, Andy, thanks for your scientific knowledge here. And we have not released yet. All the data and we continue to build upon this new MOA, and we anticipate to share with the FDA early next year when we will have, the full dataset. So it is a little bit early for me to discuss about it. But, obviously, we will present at scientific meetings, and, share with the FDA with the impact that we believe, that, this supplemental, important, MOA for them and totally unique. John, you want to address the second question of Andy? John F. Vavricka: Sure. Thanks, Andy. Yes. Test-and-treat is what the KOLs are looking to with they do believe will actually increase the number of patients that are treated. And then you are correct that the way to the way that they would like to practice it is the patient is diagnosed and then immediately treated. This is like the other products that are out there. So we will have both bottles and for the blister packs. And similar to the other products you would if you would have to likely--for, you know--a kit, you know, give, you know, 2 blister packs out if that is what the patient required or 2 bottles out, very similar to what you have going on today. The reason for the blister packs was it was just identified as a more convenient way for the HCV patients. And we are trying to do everything we can to make them take their medication and be more adherent. it is just a matter of the quantity that you will give them at that time. That answer your question, Andy? Andy Hsieh: Yeah. So I guess the question also has to do with kind of the refilling requirements. So after the first month, you know, based on payers or other stakeholders, Basically, how do you eliminate that tool or step to get a refill? John F. Vavricka: So I do not have that answer for you today. What I can tell you is that in talking with physicians who do practice test and treat within their respective states, the payers for those respective states have allowed them to give the appropriate amount without a refill to those patients. And that would be specific to the programs. So you are correct. Where it is existing they do give them to everyone. Would every physician be able to provide test and treat today? that is part of the challenges and the mechanisms that will have to be worked out. What I can tell you in talking to these physicians who have implemented the test and treat, and have provided the treatment at that visit, they do see great promise and great success. The 1 thing that they are very excited about for our profile is that it really would be the best profile to use in the test-and-treat because of the potential lack of drug interactions and not have to worry about what a patient is either taking now or will be taking, and will offer the shortest course of therapy. Andy Hsieh: Great. Thanks so much. Operator: Our next question comes from Jonathan Miller with Evercore ISI. Please go ahead. Xueyen Yang: Hello. This is Xueyan Yang on for Jon, Thanks for taking my question, and congrats again on the Phase 3 data. So I would like to touch on the AASLD simplified treatment algorithm. So can you walk us through the process and timeline to get the treatment included in the guideline, and what evidence do you think will be most important for the panel to see from the CBEYOND and C-FORWARD results to include them in the treatment algorithm. Thank you. Jean-Pierre Sommadossi: Arantxa, do you want to address that? Maria Arantxa Horga: Sure. They are looking for is best in class profile. So this is what we are offering here. it is the 8 week for the majority of the patients. And, you know, once they see these results and we obviously get a label and an approval, I think that it will not, be difficult with this profile to get into treatment algorithms. And, you know, have it prescribed by physicians. We are hearing really excellent feedback from our PIs. Xueyen Yang: Okay. Thank you. Jean-Pierre Sommadossi: I just want to add 1 point is that for both the North American trial and the C-FORWARD, also in 17 countries. it is absolutely remarkable That we were able to fully enroll about 900 patients in less than 8 months. So with 120 clinical sites. With a high demand. And we could see at the end that the demand was going exponentially, and we have actually to unfortunately, stop because we could not go beyond, much more in term of the number of targeted patients. But there was really a high demand for this clinical trial. In both North America, The US, as well as, in these 17 countries. Next question, please. Operator: Thank you. Our next question comes from Maxwell Skor with Morgan Stanley. Please go ahead. Maxwell Skor: Great. Thank you very much for taking my question. And congrats on the update. Regarding the non inferiority, which also cleared on the per protocol secondary in C-BEYOND, which is the C-FORWARD's primary endpoint for the EMA. How much does that lift your confidence going into the early Q1 2027 readout? Also, how comparable do you expect the baseline characteristics to be across the 2 studies given C FORWARD's different geographies and genotype mix. And finally, if I can ask just 1 more, maybe elaborate a bit more on the pricing reforms, the Medicare Part D and 340B. And how they are reshaping the competitive landscape. Thank you. Jean-Pierre Sommadossi: Sure. Great question. Arantxa, you want to tackle that? Then we are going to report that at a scientific meeting. But we do not worry. Obviously, we always worry. But we do not worry on the per protocol. As you have seen, there is quite a bit of discontinuation, but we have sufficient power. so I want you to chime in as well and address the difference of patients, which actually is substantial. Arantxa, can you go ahead? Maria Arantxa Horga: Yes. I think Maxwell, I mean, it is a great question. So for C-FORWARD, we are more likely to see genotypes, obviously, that are not in The United States. So the United States is predominantly 1a. Ex U.S., we are going to be seeing more of the 1b's. And then some of the rare genotypes that we made an extraordinary effort to get, genotypes 6, 5, which are not common in The United States. And so it will differ in terms of genotypes, but I want to remind you that a lot of these genotypes we already treated in phase 2, where we had excellent results for genotype 3 in particular excellent results. In terms of the population, we think we will see probably less transmission through the IV drug use that kind of population that we also saw in the phase 2. Because globally, there is still quite a lot of transmission through things like dental procedures, transplants, even blood transfusions. And the population ex US in general, tends to report less frequently adverse events They tend to be less lost to follow-up. They tend to be a little more compliant with the protocol. So if anything, we think we are gonna be seeing a more adherent population and maybe even a little bit closer to what we saw in the phase 2. Where we had excellent results. I think that was your, main question for me. There was another 1, though. Oh, yes. Yeah. Sorry. Jean-Pierre Sommadossi: About pricing for John? John F. Vavricka: Sure. So Max, I think your question was on pricing reform and the various, you know, 340B and other legislative 340B's reshaping the landscape and you are correct. And it depends on what segment that you are more heavily weighted. Currently, the 2 products, either Mavyret or Epclusa, have different percentages of their business coming from Medicaid or Medicare. And those changes have already started to take effect. So for instance, having a higher percentage of Medicare patients, Inflation Reduction Act has had an effect on that in the past. Manufacturers were not responsible for percentage of the total cost there, and that is happening now. As far as the other things you mentioned, like reference pricing and so forth, which is, you know, MFN-type pricing and its effect on Medicaid, You know, it could affect the Medicaid discounts. That are currently being offered. there is something interesting, Maxwell, and that is when you start looking at the pricing differential between The US, for instance, and a lot of these reference pricing are mainly EU countries or Western countries, the pricing is not as dramatically different from The US as other types of pharmaceutical products. And we were kind of shocked at that. So the impact will not be as dramatic as some people think. The other thing to bear in mind is that some manufacturers are already cutting direct deals with individual state Medicaid agencies beyond the statutory discounts to be provided. And so from that standpoint, difference between the extra rebates that they are already providing and what this reference pricing or the extra rebates for MFN might be which could theoretically be smaller. But that is what we know now. Other last thing you mentioned was 340B. I think the proposed legislative and the administrative changes are happening for 340B. I think will be favorable to the manufacturers in the sense that if the current thinking goes through instead of providing an outright discounted price, that it would be handled through a rebate mechanism thus allowing the manufacturers to make sure that they are not getting double counted on both Medicaid and 340B. But we will have to stay tuned to see what happens with that. Maxwell Skor: Great. Jean-Pierre Sommadossi: Thank you very much. I want to call back--Maxwell, I want to go back just to make sure that there is no misunderstanding here. On the C-FORWARD, the per-protocol core is the primary endpoint for the EMA. But for the FDA, the MIPT is the primary endpoint. Okay? So please be aware that the MITT as C-BEYOND or C-FORWARD, the primary endpoint for the FDA will be the MITT. So, essentially, we will have 2 primary endpoints in C-FORWARD. I hope that is okay. Maxwell Skor: Thank you very much. Thank you for clarifying. Appreciate it. Jean-Pierre Sommadossi: Thanks. Okay. Very good. Thank you, Maxwell. And any other questions? So thank you all for joining our second quarter conference call. And thank you for your continued support. Operator: This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation. Thank you. Before you buy stock in Atea Pharmaceuticals, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Atea Pharmaceuticals wasn’t one of them. The 10 stocks that made the cut are built for long-term growth and could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $419,408!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,348,694!* That performance is why people listen. 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Atea (AVIR) Q2 2026 Earnings Call Transcript was originally published by The Motley Fool

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. The Phase 3 C-BEYOND trial successfully met primary and secondary endpoints, demonstrating statistical non-inferiority of bemrusasvir to the standard of care, Epclusa. Management attributes the trial's success to its performance in a 'real-world' patient population characterized by high rates of injection drug use, psychiatric disorders, and polypharmacy. The strategic value of bemrusasvir lies in its 8-week treatment duration for non-cirrhotic patients, compared to the 12-week requirement for sofosbuvir/velpatasvir. Atea is positioning its regimen as a 'best-in-class' solution due to its protease inhibitor-free composition, which minimizes drug-drug interactions (DDIs) common in polymedicated patients. The company identifies a widening gap in the HCV market where new infections outpace annual treatments, creating an expanding addressable market of approximately 4 million people in the U.S. Operational focus is shifting toward a 'test-and-treat' model, designed to simplify diagnosis and treatment initiation at the same point of care to reduce patient attrition. Top-line results for the second Phase 3 trial, C-FORWARD, are expected in early Q1 2027 to support a pangenotypic regulatory package. Management anticipates an NDA submission in Q2 2027, with a projected commercial launch in mid-2028. Financial guidance projects that the current cash runway of $219.5 million will extend through 2027, covering key regulatory and clinical milestones. The company expects a short time to profitability post-launch, supported by a concentrated prescriber base that can be reached with a specialized sales force of 75 to 100 personnel. Peak annual U.S. net revenue is estimated to exceed $700 million, with potential to expand the total addressable market to $2.5 billion annually. Initiated a Phase 1 trial for AT-587, a potential first-in-class treatment for chronic hepatitis E, with proof-of-concept data expected in 2027. Management noted that current SVR (cure) rates in real-world settings often fall below label claims from a decade ago due to adherence challenges in modern patient populations. The company is utilizing a 4-week dosing blister card packaging strategy specifically to mitigate the risk of patient non-adherence and treatment discontinuation. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management explained that the test-and-treat model allows for immediate dispensing of the full treatment course (bottles or blister packs) at the point of diagnosis. The regimen's low risk of drug interactions is cited as a critical enabler for this model, as it reduces the need for specialist referrals or complex medication reviews. While payers in some states already support this model, management acknowledged that broader implementation and the mechanisms for all physicians to provide it remain a work in progress. Management expressed high confidence in C-FORWARD, noting that the trial is enriched for genotypes 1b, 3, 4, 5, and 6 to enable a broad global label. The ex-U.S. population in C-FORWARD is expected to be more adherent and report fewer adverse events than the North American cohort in C-BEYOND. Clarified that while the FDA uses the Modified Intent-to-Treat (MITT) population as the primary endpoint, the EMA focuses on the Per Protocol population. Management anticipates that the Inflation Reduction Act and 340B changes will be manageable, as HCV pricing in the U.S. is less divergent from international markets than other drug classes. Proposed 340B administrative changes moving toward a rebate mechanism are viewed as favorable to prevent 'double counting' of discounts with Medicaid. Atea plans to price bemrusasvir in line with existing branded DAA regimens.

Interested in Atea Pharmaceuticals, Inc.? Here are five stocks we like better. Atea’s Phase III C-BEYOND trial met its primary and secondary endpoints in chronic hepatitis C, with bemnifosbuvir/ruzasvir delivering a 93.9% sustained virologic response rate versus 94.8% for Epclusa and meeting the prespecified non-inferiority margin. The company completed enrollment in its second Phase III study, C-FORWARD, with results expected in early 2027; assuming positive data, Atea plans to file a U.S. New Drug Application in the second quarter of 2027. Atea ended Q2 with $219.5 million in cash and marketable securities, expects funding to last through 2027, and projects potential peak U.S. annual net revenue above $700 million for its hepatitis C regimen. Atea Pharmaceuticals (NASDAQ:AVIR) reported positive top-line results from its Phase III C-BEYOND trial of bemnifosbuvir/ruzasvir for chronic hepatitis C virus, saying the study met its primary and secondary endpoints against the standard-of-care regimen sofosbuvir/velpatasvir, marketed as Epclusa. The company also said its second Phase III hepatitis C trial, C-FORWARD, has completed enrollment and is expected to report top-line results in early 2027. Atea ended the second quarter with $219.5 million in cash and marketable securities and said it expects its cash runway to extend through 2027. → SoundHound AI Sends a Loud Signal After Its Q2 Earnings Beat C-BEYOND was a randomized, active-control non-inferiority study conducted at approximately 120 sites in the U.S. and Canada. The trial enrolled patients with chronic hepatitis C, including people co-infected with HIV and patients across hepatitis C genotypes common in North America. Patients without cirrhosis received bemnifosbuvir/ruzasvir for eight weeks or sofosbuvir/velpatasvir for 12 weeks. Patients with compensated cirrhosis received 12 weeks of treatment in either arm. → AST SpaceMobile Earnings Just Reminded Investors How Risky Space Can Be In the modified intent-to-treat population, bemnifosbuvir/ruzasvir achieved a sustained virologic response rate of 93.9% at week 24, compared with 94.8% for sofosbuvir/velpatasvir. Atea said the result met the trial’s prespecified 5% non-inferiority margin. The modified intent-to-treat population included patients who received at least one dose, including those who discontinued treatment, did not adhere to the protocol or were lost to follow-up. Among non-cirrhotic patients, the eight-week bemnifosbuvir/ruzasvir regimen produced a 93.5% sustained virologic response rate, compared with 94.6% for 12 weeks of sofosbuvir/velpatasvir. In patients with compensated cirrhosis, both arms reported a 95.4% response rate. Atea noted that these subgroups were not powered for statistical analysis. → First Solar’s Profit Engine Faces a New Policy Test in Washington Chief Medical Officer Arantxa Horga said the trial enrolled a population reflecting current treatment challenges in North America. More than half of participants reported injection drug use as the route of hepatitis C transmission, about 89% were taking concomitant medications, and two-thirds had a psychiatric disorder, according to the company. Horga said adverse events were comparable between the treatment arms, with most treatment-emergent events mild to moderate. There were no serious adverse events attributed to either study drug and no early discontinuations attributed to treatment. The sofosbuvir/velpatasvir arm had three deaths, none of which were considered related to the study drug, while there were no deaths in the bemnifosbuvir/ruzasvir arm. Atea’s C-FORWARD study, conducted outside North America, enrolled more than 880 patients and is designed to support a broad pan-genotypic regulatory package. The study includes greater representation of genotypes 1b, 3, 4, 5 and 6 than C-BEYOND, management said. Chief Executive Officer Jean-Pierre Sommadossi said C-FORWARD is expected to provide top-line data in early first-quarter 2027. Pending positive results, Atea anticipates submitting a New Drug Application to the Food and Drug Administration in the second quarter of 2027. During the question-and-answer session, Sommadossi clarified that the modified intent-to-treat analysis will serve as the primary endpoint for the FDA in C-FORWARD, while the per-protocol analysis is the primary endpoint for the European Medicines Agency. Atea said it believes bemnifosbuvir/ruzasvir could offer an eight-week regimen for non-cirrhotic patients, without a protease inhibitor, with low potential for drug-drug interactions and no food effect. Chief Development Officer Janet Hammond said the company expects broad compatibility with several categories of concomitant medicines, including certain HIV treatments, statins, immunosuppressants, digoxin and acid-reducing therapies. Chief Commercial Officer John Vavricka said the company sees an opportunity in the gap between newly diagnosed hepatitis C infections and the number of patients treated. According to Atea, about half of newly infected patients were treated in 2025, and the U.S. hepatitis C-infected population is approaching 4 million people. Vavricka said Atea expects its regimen could be suited to a “test-and-treat” model, in which patients are diagnosed and begin treatment during the same visit. The company plans to offer both bottles and four-week blister packs, although Vavricka said payer requirements governing whether patients can receive the full course without a refill will vary by program and state. Atea’s market research among high-volume direct-acting antiviral prescribers found that 76% said they would be extremely likely to prescribe bemnifosbuvir, according to the company. Management projected potential peak annual U.S. net revenue exceeding $700 million and said it expects pricing to be in line with existing branded hepatitis C regimens. The company also said it expects a focused commercial organization of roughly 75 to 100 personnel could reach most of the U.S. prescriber base. In July, Atea initiated a first-in-human Phase I trial of AT-587, a potential direct-acting antiviral for chronic hepatitis E. The randomized, double-blind, placebo-controlled trial is being conducted in healthy volunteers and will assess safety, tolerability and pharmacokinetics through single-ascending-dose and multiple-ascending-dose phases, as well as a food-effect assessment. Hammond said the company had completed the first cohort and was proceeding to the next cohort. Atea said there is currently no approved therapy for hepatitis E and that it is targeting proof of concept for AT-587 in 2027. Chief Financial Officer Andrea Corcoran said research and development expense increased in the first six months of 2026 from a year earlier, driven primarily by external spending on the hepatitis C Phase III program and hepatitis E preclinical and clinical startup work. General and administrative expense declined, primarily due to lower salaries, wages and stock-based compensation. The company said most spending in the second half of 2026 will remain directed toward completing C-FORWARD, preparing regulatory filings and conducting pre-launch activities for its hepatitis C program. Atea Pharmaceuticals, Inc is a clinical-stage biopharmaceutical company focused on the discovery and development of oral antiviral therapeutics targeting RNA viruses. The company's lead program, AT-527, is a direct-acting nucleotide prodrug licensed from Roche and is being evaluated as a potential treatment for coronavirus disease 2019 (COVID-19). In addition to its COVID-19 efforts, Atea's pipeline includes other small-molecule candidates for hepatitis C virus and emerging RNA pathogens, leveraging its proprietary nucleotide chemistry platform to address significant unmet medical needs in infectious diseases. Founded in 2014 and headquartered in Cambridge, Massachusetts, Atea operates research laboratories in the Greater Boston area and conducts clinical studies across North America, Europe and parts of Asia. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Atea Pharmaceuticals Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

Phase 3 C-BEYOND Trial Met Primary and Secondary Endpoints, with a Short 8-week Duration for Patients Without Cirrhosis Supporting a Potential Best-in-Class Profile of BEM/RZR for Treatment of HCV C-FORWARD Phase 3 Trial Outside North America on Track with Topline Results Expected Early Q1 2027 AT-587 Phase 1 Clinical Trial Advancing for Treatment of Hepatitis E Virus (HEV) Company Holding Conference Call Today at 4:30 pm ET BOSTON, Aug. 12, 2026 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (Atea or Company), a late-stage clinical biopharmaceutical company engaged in the discovery and development of oral antiviral therapeutics for serious viral diseases, today reported financial results for the second quarter ended June 30, 2026, and provided a business update. In July, Atea announced positive topline results from C-BEYOND, its Phase 3 trial conducted in North America evaluating the regimen of bemnifosbuvir and ruzasvir (BEM/RZR) for the treatment of chronic hepatitis C virus (HCV) infection compared to the regimen of sofosbuvir and velpatasvir (SOF/VEL; Epclusa) in the modified intent-to-treat (mITT) population, achieving the trial’s primary endpoint. C-BEYOND enrolled patients reflective of the current real-world population living with HCV in the US and Canada. Patients in C-BEYOND included those who are taking concomitant medications (~89%), reported injection drug use as the HCV route of transmission (≥ 55%), diagnosed with a comorbid psychiatric disorder (~66%), prematurely discontinued treatment, lost to follow-up or did not adhere to protocol treatment (>10%), underscoring the importance of a simplified treatment option with a short 8-week duration for most patients, low risk of drug-drug interactions, and convenience with no food effect. "The positive Phase 3 C-BEYOND results announced last month represent a pivotal milestone for Atea, validating BEM/RZR's potential to become a highly differentiated, best-in-class treatment for hepatitis C virus (HCV)," said Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of Atea Pharmaceuticals. "In the US, a significant HCV treatment gap remains, currently only about 50%, or 85,000 people diagnosed are being treated annually, contributing to the increasing population of up to four million people who are already chronically infected. BEM/RZR's differentiated profile with a short eight-week regimen for non-cirrhotic patients, a low risk of drug-drug interactions and no food restrictions, has the potential to streamline prescribing decisions, and help expand treatment to more patients.” “Looking ahead, we remain focused on delivering topline results from our second Phase 3 trial, C-FORWARD, in early first quarter 2027 while continuing to advance AT-587 for the treatment of HEV, where a substantial commercial opportunity remains due to the lack of any approved therapies," Dr. Sommadossi added. Viral Hepatitis Pipeline Updates Hepatitis C (HCV) C-BEYOND topline Phase 3 results include: In the modified intent to treat (mITT) primary endpoint analysis (n=905, cirrhotic and non-cirrhotic), BEM/RZR achieved a 93.9% sustained virologic response (SVR) rate vs. 94.8% for SOF/VEL (marketed in the US under the brand] Epclusa®) at Week 24, encompassing SVR at 12 weeks (accepted definition of cure for HCV) in both arms. The trial achieved its primary endpoint of statistical non-inferiority, with a 95% confidence interval for difference in SVR rates within the prespecified 5% margin. Statistical non-inferiority was also met in secondary endpoints, including the per-protocol analysis. The mITT analysis in patients without cirrhosis (n=721) showed BEM/RZR (8 weeks of treatment) achieved a 93.5% SVR rate vs. 94.6% for SOF/VEL (12 weeks of treatment). In patients with cirrhosis (12 weeks treatment in both arms) (n=184), BEM/RZR achieved a 95.4% SVR rate vs. 95.4% for SOF/VEL. Rates of virologic failure across all populations were low and comparable between treatment arms. BEM/RZR was generally safe and well tolerated with no drug-related serious adverse events or drug related early treatment discontinuations, and safety was comparable between treatment arms. Today, the US Centers for Disease Control (CDC) reports approximately 160,000 new HCV infections annually with only an estimated 85,000 patients1 receiving treatment with the current standard of care therapies leaving approximately 75,000 untreated annually, enabling a potential $2.5 billion annual net sales US market opportunity. In the US alone, up to 4 million people are estimated to be infected with HCV. The C-BEYOND results reinforce BEM/RZR’s potential to address this growing treatment gap in today’s patient population and contribute to advancing the World Health Organization’s HCV elimination goal. Atea is advancing C-FORWARD, its second Phase 3 trial, being conducted outside North America. Patient enrollment for C-FORWARD was completed in June 2026 with more than 880 patients across 17 countries. Topline results are expected in early Q1 2027 and will provide additional efficacy data across a broader range of HCV genotypes more commonly found outside of the US and Canada. Following the recent topline readout for C-BEYOND and pending results from C-FORWARD, Atea anticipates submitting a new drug application (NDA) to the US Food & Drug Administration (FDA) in the second quarter of 2027. ______________ 1 IQVIA: NRx (NPA) Audit for the period Jan 2025 – Dec 2025 reflecting estimates of real-world activity. Hepatitis E (HEV) In July, Atea initiated a first-in-human Phase 1 clinical trial evaluating, AT-587, for the treatment of chronic HEV. Atea’s focus will be in an immunocompromised patient population infected with HEV genotypes 3 or 4. There is currently no approved antiviral therapy for HEV and current off-label treatments, including ribavirin, have limited efficacy and tolerability, underscoring a clear and urgent unmet medical need. Second Quarter 2026 Financial Results Cash and Investments: $219.5 million at June 30, 2026 compared to $301.8 million at December 31, 2025. Research and Development Expenses: Research and development expenses decreased by $4.1 million from $32.3 million for the three months ended June 30, 2025 to $28.2 million for the three months ended June 30, 2026. The net decrease was primarily driven by a decrease in external spend for our HCV Phase 3 clinical development offset by an increase in external spend for HEV preclinical development and clinical development startup activities. The decrease in HCV Phase 3 clinical development external spend was principally the result of the completion of the Week 24 post treatment visits by patients in our C-BEYOND Phase 3 clinical trial.   The decrease in internal research and development expenses was primarily related to lower stock-based compensation expense in the three months ended June 30, 2026. General and Administrative Expenses: General and administrative expenses decreased by $2.1 million from $9.1 million for the three months ended June 30, 2025 to $7.0 million for the three months ended June 30, 2026. The net decrease was primarily related to lower stock-based compensation expense and lower professional fees. Interest Income and Other, Net: Interest income and other, net, decreased by $2.2 million for the three months ended June 30, 2026 compared to the three months ended June 30, 2025, primarily due to lower investment balances. Income Taxes: Income tax expense was $0.1 and $0.2 million for the three months ended June 30, 2026 and 2025, respectively. Conference Call and Webcast Atea will host a conference call and live audio webcast to discuss second quarter 2026 financial results and provide a business update today at 4:30 p.m. ET. To access the live conference call, participants may register here. The live audio webcast of the call will be available under "Events and Presentations" in the Investor Relations section of the Atea website at ir.ateapharma.com. To participate via telephone, please dial 1-877-407-0779 (U.S.) or 1-201-389-0914 (International) and use conference ID number 13761501. An archive of the audio webcast will be available on Atea’s website approximately two hours after the conference call and will remain available for at least 90 days following the event. About the C-BEYOND and C-FORWARD Phase 3 Trials in Adults with Chronic HCV The global Phase 3 program is evaluating the fixed-dose combination (FDC) of BEM/RZR for the treatment of chronic HCV in patients with and without compensated cirrhosis. The program consists of two open-label controlled trials, which have collectively enrolled over 1,760 treatment-naïve patients: C-BEYOND (NCT06868264) in North America and C-FORWARD (NCT07037277) outside North America. The trials compare the FDC regimen of bemnifosbuvir (BEM), a nucleotide analog polymerase inhibitor, and ruzasvir (RZR), an NS5A inhibitor, to the FDC regimen of SOF/VEL. The regimen of BEM/RZR is administered orally once daily for eight weeks (in patients without cirrhosis) or 12 weeks (in patients with compensated cirrhosis), while the regimen of SOF/VEL is administered orally once daily for 12 weeks to all patients, with or without compensated cirrhosis. The primary endpoint for each trial is HCV RNA below the lower limit of quantitation (LLOQ) at 24 weeks from the start of treatment and encompasses sustained virologic response 12 weeks post-treatment (SVR12) in each arm. SVR12 is the accepted definition of cure for HCV. Measurement at 24 weeks from the start of treatment is to ensure the primary endpoint measurement occurs at the same relative timepoint from the start of treatment in all patients. The primary endpoint was assessed in the mITT population in C-BEYOND, which is comprised of all patients who received at least one dose of the regimen and includes patients who discontinued early, were not compliant or were lost to follow-up. The mITT analysis is the agreed upon primary endpoint with the FDA. About Bemnifosbuvir and Ruzasvir for HCV BEM has been shown in in vitro studies to be approximately 10-fold more active than sofosbuvir (SOF) against a panel of laboratory strains and clinical isolates of HCV GT 1–5. In vitro studies have also demonstrated BEM remained fully active against SOF resistance-associated substitutions (S282T), with up to 58-fold more potency than SOF. The pharmacokinetic (PK) profile of BEM supports once-daily dosing for the treatment of HCV. BEM has been shown to have a low risk for drug-drug interactions. BEM has been administered to over 3,200 subjects and has been well-tolerated at doses up to 550 mg for durations up to 12 weeks in healthy subjects and patients. RZR has demonstrated highly potent and pan-genotypic antiviral activity in preclinical (picomolar range) and clinical studies. RZR has been administered to over 3,100 HCV-infected patients at daily doses of up to 180 mg for 12 weeks and has demonstrated a favorable safety profile. The PK profile of RZR supports once-daily dosing. About HCV HCV is a blood-borne, positive-sense, single-stranded RNA (ssRNA) virus that primarily infects liver cells. HCV is a leading cause of chronic liver disease and liver transplants, spreading via blood transfusion, hemodialysis and needle sticks, with approximately 240,000 deaths occurring each year. Despite the availability of DAAs, HCV continues to be a significant global healthcare issue. An estimated 50 million people worldwide are chronically infected with HCV and there are approximately one million new infections each year. In the US, as many as four million people are estimated to have HCV with annual new infections outpacing treatment rates. HCV infections in the US predominate in patients in the age group between 20 and 49 years old, and it is estimated that approximately 80-90% of people living with HCV in the US do not have cirrhosis. Chronic HCV infection is a leading cause of liver cancer in the US, Europe and Japan. About HEV HEV is a positive sense, ssRNA virus which infects the liver and remains an under-recognized global health challenge with an estimated 20 million infections annually. Waterborne transmission of HEV genotypes 1 and 2 causes mostly acute self-limiting hepatitis in developing regions, whereas foodborne transmission of HEV genotype 3 predominates in the US and Europe and causes chronic hepatitis in immunocompromised patients, which can lead to cirrhosis in three to five years. There is a growing number of immunocompromised patients, a population that includes solid organ transplant and hematopoietic stem cell transplant recipients and patients with hematologic malignancies such as multiple myeloma. Each year, in the US and Europe, 3% of the approximately 665,000 patients who have these underlying medical conditions are at risk of developing chronic HEV. There is currently no approved antiviral therapy for HEV, and current off-label treatments have limited efficacy and tolerability, underscoring a clear and urgent unmet medical need. Atea’s initial HEV clinical efforts are focused on developing AT-587 for the treatment of immunocompromised patients with chronic HEV. About Atea Pharmaceuticals Atea is a late-stage clinical biopharmaceutical company focused on discovering, developing and commercializing oral antiviral therapies to address the unmet medical needs of patients with serious viral infections. Leveraging Atea’s deep understanding of antiviral drug development, nucleos(t)ide chemistry, biology, biochemistry and virology, Atea has built a proprietary nucleos(t)ide prodrug platform to develop novel product candidates to treat ssRNA viruses, which are a prevalent cause of serious viral diseases. Atea plans to continue to build its pipeline of antiviral product candidates by augmenting its nucleos(t)ide platform with other classes of antivirals that may be used in combination with its nucleos(t)ide product candidates. Atea’s Phase 3 program is evaluating the FDC regimen of BEM, a nucleotide analog polymerase inhibitor, and RZR, an NS5A inhibitor, to treat HCV. AT-587, a nucleotide analog, is in Phase 1 development for the treatment of HEV. For more information, please visit www.ateapharma.com. Forward-Looking Statements This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include but are not limited to statements regarding the potential best-in-class profile of the BEM/RZR regimen for the treatment of HCV, the potential opportunity to advance efforts to eradicate HCV, the potential to develop a product for the treatment of HEV, anticipated milestone events and timelines including the timeline for readout of the C-FORWARD Phase 3 clinical trial results and the potential submission of an NDA for US marketing approval of BEM/RZR, future results of operations and business strategy. When used herein, words including “expected,” “should,” “anticipated,” “believe,” “will,” “plans”, and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Atea’s current expectations and various assumptions. Atea believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Atea may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, uncertainties inherent in the drug discovery and development process and the regulatory submission or approval process, unexpected or unfavorable safety or efficacy data or results observed during clinical trials or in data readouts; delays in or disruptions to clinical trials or our business; our reliance on third parties over which we may not always have full control; our ability to manufacture sufficient commercial product; competition from approved treatments for HCV; dependence on the success of Atea’s most advanced product candidates, in particular the BEM/RZR regimen for the treatment of HCV; as well as the other important factors discussed under the caption “Risk Factors” in Atea’s Annual Report on Form 10-K for the year ended December 31, 2025 as such factors may be updated from time to time in its other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. All forward-looking statements represent management’s estimates as of the date of this press release. While Atea may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause our views to change. Forward-looking statements should not be relied upon as representing Atea’s views as of any date subsequent to the date of this press release. Contacts Jonae BarnesSVP, Investor Relations and Corporate [email protected] Joyce AllaireLifeSci [email protected]

BOSTON, Aug. 05, 2026 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (Atea or Company), a late-stage clinical biopharmaceutical company engaged in the discovery and development of oral antiviral therapeutics for serious viral diseases, today announced that it will host a live conference call and audio webcast on Wednesday, August 12, 2026, at 4:30 p.m. ET to report financial results for the second quarter ended June 30, 2026, and to provide a business update. To access the live conference call, participants may register here. The live audio webcast of the call will be available under “Events and Presentations” in the Investor Relations section of the Atea Pharmaceuticals website at ir.ateapharma.com. To participate via telephone, please dial 1-877-407-0779 (U.S.) or 1-201-389-0914 (International) and use conference ID number 13761501. An archive of the audio webcast will be available on Atea’s website approximately two hours after the conference call and will remain available for at least 90 days following the event. About Atea Pharmaceuticals Atea is a late-stage clinical biopharmaceutical company focused on discovering, developing and commercializing oral antiviral therapies to address the unmet medical needs of patients with serious viral infections. Leveraging Atea’s deep understanding of antiviral drug development, nucleos(t)ide chemistry, biology, biochemistry and virology, Atea has built a proprietary nucleos(t)ide prodrug platform to develop novel product candidates to treat single-stranded ribonucleic acid, or ssRNA, viruses, which are a prevalent cause of serious viral diseases. Atea plans to continue to build its pipeline of antiviral product candidates by augmenting its nucleos(t)ide platform with other classes of antivirals that may be used in combination with its nucleos(t)ide product candidates. Atea’s Phase 3 program is evaluating the fixed dose combination regimen of bemnifosbuvir, a nucleotide analog polymerase inhibitor, and ruzasvir, an NS5A inhibitor, to treat hepatitis C virus (HCV). Atea is also currently conducting a Phase 1 clinical study of AT-587, a nucleotide analog, for the treatment of hepatitis E virus (HEV). For more information, please visit www.ateapharma.com Forward-Looking StatementsThis press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include but are not limited to the Company’s plans relating to the date and time of the anticipated conference call and audio webcast. When used herein, words including “may,” “will,” “anticipates,” “plans,” and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon the Company’s current expectations and various assumptions. The Company believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. The Company may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, the important factors discussed and updated from time to time under the caption “Risk Factors” in the reports the Company files with the SEC, including annual reports on Form10-K, quarterly reports on Form10-Q, current reports on Form 8-K and other filings each of which are accessible on the SEC’s website at www.sec.gov. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. All forward-looking statements represent management’s estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause our views to change. Forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this press release. Contacts Jonae BarnesSVP, Investor Relations and Corporate [email protected] Joyce AllaireLifeSci [email protected]

Additional Data Presented Demonstrate High In Vitro Antiviral Potency and In Vivo Efficacy for AT-587, Atea’s Potential First-in-Class Direct-Acting Antiviral for the Treatment of Hepatitis E Virus BOSTON, May 27, 2026 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (Atea or Company), a late-stage clinical biopharmaceutical company engaged in the discovery and development of oral antiviral therapeutics for serious viral diseases, today announced Phase 1 results which further demonstrate that the fixed-dose combination regimen of bemnifosbuvir and ruzasvir (BEM/RZR) for the treatment of hepatitis C virus (HCV) has a low risk of drug-drug interaction. These results support the use of BEM/RZR with commonly used medications, including the proton pump inhibitor (PPI) omeprazole and the cholesterol-lowering drug rosuvastatin. The Company is also presenting data demonstrating high in vitro antiviral potency and in vivo efficacy for AT-587, its potential first-in-class direct-acting antiviral (DAA) for the treatment of hepatitis E virus (HEV). These data are being presented at the European Association for the Study of the Liver (EASL) Congress 2026, taking place May 27-30th in Barcelona, Spain. “These Phase 1 results reinforce the potential of the regimen of BEM/RZR to simplify treatment for patients and healthcare providers and address the evolving needs of today’s patients living with HCV,” said Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of Atea Pharmaceuticals. “Our market research has shown that most HCV patients in the US manage multiple medications concurrently, which can complicate care. The results being presented demonstrate that the regimen of BEM/RZR can be co-administered with PPIs and other commonly used medications without requiring dose adjustments. As we move toward topline Phase 3 results from C-BEYOND and C-FORWARD, these data give us continued confidence in the regimen's potential to deliver a best-in-class profile for today’s patients living with HCV.” HCV continues to be a significant global health burden despite the availability of DAAs. According to US healthcare providers who treat patients with HCV, approximately 80 percent of patients take multiple medications to manage comorbidities and drug-drug interactions are a significant concern in HCV treatment. As a result, a new treatment option offering a low risk of drug-drug interactions together with high efficacy and short treatment duration could meaningfully address patient needs and further the goal of HCV eradication. “The data being presented for AT-587 demonstrate high in vitro antiviral potency and in vivo efficacy against HEV, underscoring its potential,” Dr. Sommadossi added. “There is a critical gap in the care of patients with chronic HEV with no approved therapies, leaving vulnerable populations including transplant recipients and other immunocompromised patients at risk for rapid disease progression to cirrhosis. Following the encouraging preclinical data, we look forward to advancing our potential first-in-class product candidate, AT-587, into a first-in-human study mid-year.”In recent years, chronic HEV genotype 3 and 4 infections have been increasingly recognized as a potentially life-threatening viral infection in immunocompromised individuals — a population that includes solid organ and hematopoietic stem-cell transplant recipients, and patients with hematologic malignancies. In these vulnerable populations, chronic HEV can result in rapid progression to cirrhosis within three to five years. There is no approved antiviral therapy for HEV, and current off-label treatments have limited efficacy and tolerability, underscoring a clear and urgent unmet medical need. Phase 1 Results for the Regimen of BEM/RZR Highlight Favorable Drug-Drug Interaction Profile for Treatment of HCV Poster ID: FRI-635 Title: Proton-pump inhibitor omeprazole did not affect the plasma pharmacokinetics of bemnifosbuvir and ruzasvir fixed-dose combination in healthy participantsPresenting Author: Xiao-Jian ZhouDate and Time: Friday, May 29, 8:30 a.m.–5:00 p.m. CESTA Phase 1 study in healthy adults (n=20) showed the regimen of BEM/RZR was generally safe and well-tolerated when administered alone or concomitantly with omeprazole, a commonly used medication among HCV-infected patients to treat stomach acid conditions. These results support co-administration of BEM/RZR with PPIs, which often reduce the solubility of DAAs, decreasing their absorption/bioavailability and negatively impacting DAA efficacy. Omeprazole dosed at 20 mg, a common dose for gastroesophageal reflux disease, did not affect plasma exposure to BEM/RZR. Omeprazole dosed at 40 mg administered two hours before BEM/RZR to allow maximal acid-suppressive effect only slightly reduced plasma exposure to BEM/RZR. Co-administered BEM/RZR did not meaningfully affect the pharmacokinetic (PK) profile of omeprazole. Poster ID: FRI-636 Title: Bemnifosbuvir and ruzasvir administered as a fixed-dose combination have low potential to inhibit P-gp, BCRP or OATP1B1/3 mediated transportPresenting Author: Xiao-Jian ZhouDate and Time: Friday, May 29, 8:30 a.m.–5:00 p.m. CESTA Phase 1 study in healthy adults evaluated interactions between the regimen of BEM/RZR and digoxin (n=18) or rosuvastatin (n=18), sensitive substrates of the drug transporters P-gp and BCRP/OATP1B1/1B3, respectively. These transporters are important for how drugs are absorbed, enter the liver and are cleared from the body. Results demonstrated that BEM/RZR administered with digoxin and rosuvastatin was well tolerated with all treatment-emergent adverse events mild in severity. A single dose of BEM/RZR slightly increased the plasma exposure of digoxin and rosuvastatin. With a geometric mean ratio of less than 2, BEM/RZR has low potential to exhibit clinically meaningful inhibition of these transporters. These results demonstrate that no dose adjustments are needed for drugs that are substrates of these transporters when co-administered with BEM/RZR. AT-587 Results Demonstrate High In Vitro Antiviral Potency and In Vivo Efficacy Against HEV Poster ID: TOP-631 Title: Discovery and preclinical profile of a first-in-class potent hepatitis E virus inhibitor AT-587Presenting Author: Qi HuangDate and Time: Thursday, May 28, 8:30 a.m.–5:00 p.m. CESTResults presented support AT-587 as an oral nucleotide analog exhibiting promising preclinical antiviral potency against HEV. In vitro studies demonstrated that AT-587 is a potent inhibitor of HEV replication. Specifically, AT-587 was 30 to 150-fold more potent in vitro against HEV than sofosbuvir (SOF) and ribavirin, which is currently used off-label. AT-587 showed no toxicity in in vitro studies. AT-587 also demonstrated activity against flaviviruses, rubella and chikungunya.In addition, new results showed that AT-587 inhibited HEV-3 activity in vivo. Using HEV-3-infected gerbil models, fecal samples from the treated groups had significantly lower HEV RNA levels than the control group. In addition, the viral loads in the liver and intestinal samples were significantly lower in the treated groups compared to control. Notably, AT-587 also retained high potency against ribavirin (G1634R) and SOF (A1343V) clinical resistance strains in vitro, further differentiating its profile from existing off-label treatment options. About Bemnifosbuvir and Ruzasvir for HCV Bemnifosbuvir has been shown in in vitro studies to be approximately 10-fold more active than SOF against a panel of laboratory strains and clinical isolates of HCV GT 1–5. In vitro studies have also demonstrated bemnifosbuvir remained fully active against SOF resistance-associated substitutions (S282T), with up to 58-fold more potency than SOF. The PK profile of bemnifosbuvir supports once-daily dosing for the treatment of HCV. Bemnifosbuvir has been shown to have a low risk for drug-drug interactions. Bemnifosbuvir has been administered to over 3,000 subjects and has been well-tolerated at doses up to 550 mg for durations up to 12 weeks in healthy subjects and patients. Ruzasvir has demonstrated highly potent and pan-genotypic antiviral activity in preclinical (picomolar range) and clinical studies. Ruzasvir has been administered to over 2,800 HCV-infected patients at daily doses of up to 180 mg for 12 weeks and has demonstrated a favorable safety profile. The PK profile of ruzasvir supports once-daily dosing. About HCV HCV is a blood-borne, single-stranded (ss) RNA virus that primarily infects liver cells. HCV is a leading cause of chronic liver disease and liver transplants, spreading via blood transfusion, hemodialysis and needle sticks, with approximately 240,000 deaths occurring each year. Despite the availability of DAAs, HCV continues to be a significant global healthcare issue. An estimated 50 million people worldwide are chronically infected with HCV and there are approximately one million new infections each year. In the US, approximately four million people are estimated to have HCV with annual new infections outpacing treatment rates. HCV infections in the US predominate in patients in the age group between 20 and 49 years old, and it is estimated that less than 10% of HCV-infected patients in the US have cirrhosis. Chronic HCV infection is a leading cause of liver cancer in the US, Europe and Japan. About HEV HEV is a ssRNA virus which infects the liver and remains an under-recognized global health challenge with an estimated 20 million acute infections annually. Waterborne transmission of HEV genotypes 1 and 2 causes mostly acute self-limiting hepatitis in developing regions, whereas foodborne transmission of HEV genotype 3 predominates in the US and Europe and may cause chronic hepatitis in immunocompromised patients, which can lead to cirrhosis in three to five years. There is a growing number of immunocompromised patients, a population that includes solid organ transplant and hematopoietic stem cell transplant recipients and patients with hematologic malignancies such as multiple myeloma. Each year, in the US and Europe, 3% of the approximately 450,000 patients who have these underlying medical conditions are at risk of developing chronic HEV. There is currently no approved antiviral therapy for HEV, and current off-label treatments have limited efficacy and tolerability, underscoring a clear and urgent unmet medical need. Atea’s initial HEV clinical efforts will focus on developing AT-587 for the treatment of immunocompromised patients with chronic HEV. About Atea Pharmaceuticals Atea is a late-stage clinical biopharmaceutical company focused on discovering, developing and commercializing oral antiviral therapies to address the unmet medical needs of patients with serious viral infections. Leveraging Atea’s deep understanding of antiviral drug development, nucleos(t)ide chemistry, biology, biochemistry and virology, Atea has built a proprietary nucleos(t)ide prodrug platform to develop novel product candidates to treat single-stranded ribonucleic acid, or ssRNA, viruses, which are a prevalent cause of serious viral diseases. Atea plans to continue to build its pipeline of antiviral product candidates by augmenting its nucleos(t)ide platform with other classes of antivirals that may be used in combination with its nucleos(t)ide product candidates. Atea’s Phase 3 program is evaluating the FDC regimen of bemnifosbuvir, a nucleotide analog polymerase inhibitor, and ruzasvir, an NS5A inhibitor, to treat HCV. Atea anticipates initiating clinical development of AT-587, a nucleotide analog, for the treatment of HEV in mid-2026. For more information, please visit www.ateapharma.com Forward-Looking Statements This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include but are not limited to statements regarding the potential best-in-class profile of the BEM/RZR regimen for the treatment of HCV, the potential to develop a product for the treatment of HEV, anticipated milestone events and timelines for clinical trials including the timeline for readout of the HCV Phase 3 clinical trials results and initiation of the HEV clinical development, future results of operations and business strategy. When used herein, words including “expected,” “should,” “anticipated,” “believe,” “will,” “plans”, and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Atea’s current expectations and various assumptions. Atea believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Atea may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, uncertainties inherent in the drug discovery and development process and the regulatory submission or approval process, unexpected or unfavorable safety or efficacy data or results observed during clinical trials or in data readouts; delays in or disruptions to clinical trials or our business; our reliance on third parties over which we may not always have full control; our ability to manufacture sufficient commercial product; competition from approved treatments for HCV; dependence on the success of Atea’s most advanced product candidates, in particular the BEM/RZR regimen for the treatment of HCV; as well as the other important factors discussed under the caption “Risk Factors” in Atea’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2026 as such factors may be updated from time to time in its other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While Atea may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing Atea’s views as of any date subsequent to the date of this press release. ContactsJonae BarnesSVP, Investor Relations and Corporate [email protected] Joyce AllaireLifeSci [email protected]

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management is executing a catalyst-rich 2026 strategy centered on two pivotal Phase III readouts for their global HCV program, with C-BEYOND data expected midyear and C-FORWARD around year-end. The HCV regimen (bemnifosbuvir and ruzasvir) is positioned as a potentially best-in-class therapy, specifically designed to address the high rate of new chronic infections that currently outpaces treatment rates in the U.S. Strategic differentiation is driven by a profile featuring short treatment duration, low drug-drug interaction risk with common medications like PPIs and statins, and no food effect, facilitating a 'test-and-treat' model. The company expanded its antiviral focus to Hepatitis E (HEV), targeting a $750 million to $1 billion annual market opportunity for immunocompromised patients who currently have no approved therapies. Operational readiness for a potential commercial launch is underway, utilizing a concentrated prescriber base of approximately 7,800 physicians to reach 80% of the market with a lean specialty sales force. Manufacturing for commercial launch supply is already in progress, supported by low cost of goods relative to expected net pricing to ensure a short timeline to profitability post-approval. Top line Phase III results for C-BEYOND are scheduled for mid-2026, followed by C-FORWARD results around the end of the year to support a broad global label. Atea expects to initiate a first-in-human Phase I study for AT-587 in Hepatitis E midyear, with a proof-of-concept study planned for year-end 2026. The company projects its current cash position of $256 million will provide a sufficient runway through 2027, covering Phase III completion and initial HEV development. Regulatory strategy for HCV includes a planned analysis combining both Phase III studies to potentially evaluate a superiority claim over the current standard of care. Future HEV clinical development may extend treatment duration from 12 weeks to 24 weeks depending on initial SVR rates and ongoing chronic toxicology studies. The HCV market remains highly competitive and concentrated, with two existing regimens currently dominating the $1.3 billion U.S. net sales landscape. HEV genotype 3 is identified as a significant risk for immunocompromised patients in the U.S. and Europe, capable of progressing to cirrhosis in only 3 to 5 years. R&D expenses increased year-over-year due to external spend for Phase III HCV trials and HEV preclinical development, though partially offset by lower internal payroll and stock-based compensation. The C-FORWARD trial is currently restricted to less prevalent genotypes (4, 5, and 6) to ensure the data supports a comprehensive regulatory label. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management confirmed they will release the primary endpoint (SVR at week 24) for both the modified intent-to-treat and per-protocol populations. Detailed secondary data will be withheld for future medical meetings or peer-reviewed publications. Launch preparations are focused on the three primary payer segments (Medicaid, Medicare, and commercial) where research suggests favorable outlook for parity access. The head-to-head nature of the Phase III trial against Epclusa is viewed as a critical lever for gaining payer acceptance and formulary inclusion. The Phase III studies are powered at 90% with a 5% noninferiority margin, but management indicated they may seek a superiority claim by combining data from both trials. Management noted that Phase II post-hoc analyses showed SVR rates of 95-98%, providing confidence in meeting Phase III targets.

Interested in Atea Pharmaceuticals, Inc.? Here are five stocks we like better. Atea Pharmaceuticals says it remains on track for two major Phase 3 hepatitis C readouts in 2026, with C-BEYOND expected in mid-2026 and C-FORWARD around year-end. Together, the trials are evaluating bemnifosbuvir and ruzasvir against Epclusa in more than 1,760 patients. The company reported $256 million in cash, cash equivalents and marketable securities at March 31, 2026, and expects its runway to last through 2027. Management said that should support completion of the HCV program and advancement of its hepatitis E work. Atea is also advancing AT-587 for chronic hepatitis E in immunocompromised patients, with a first-in-human study expected around mid-year and a proof-of-concept study planned for year-end. The company sees a meaningful unmet need and potential market opportunity for the program. Atea Pharmaceuticals (NASDAQ:AVIR) said it remains on track for two key Phase 3 hepatitis C readouts in 2026 while advancing a newer hepatitis E program aimed at immunocompromised patients with no approved treatment options. During the company’s first-quarter 2026 earnings call, Chief Executive Officer and Founder Dr. Jean-Pierre Sommadossi described the year as “catalyst rich” for Atea, citing upcoming top-line data from the company’s global Phase 3 hepatitis C virus, or HCV, program. The company is evaluating a combination regimen of bemnifosbuvir and ruzasvir against the current standard of care, sofosbuvir/velpatasvir, marketed as Epclusa. → MercadoLibre Boldly Invests in Growth: Discount Deepens Atea reported cash, cash equivalents and marketable securities of $256 million as of March 31, 2026. Chief Financial Officer Andrea Corcoran said the company expects its cash runway to extend through 2027, supporting completion of the Phase 3 HCV program and advancement of its hepatitis E virus, or HEV, development program. Sommadossi said Atea completed enrollment in C-BEYOND, its North American Phase 3 trial, late last year with more than 880 patients. The company expects top-line results from C-BEYOND in mid-2026. → Rocket Lab Just Hit a New All-Time High—Time to Buy or Let It Breathe? For C-FORWARD, the company’s ex-North America trial, Atea has completed enrollment of 95% of cirrhotic and non-cirrhotic patients and expects to finish enrollment next month, according to management. Enrollment remains open only for less prevalent genotypes, including 4, 5 and 6, to support a broad label. Atea expects top-line results from C-FORWARD around year-end. Chief Medical Officer Dr. Arantxa Horga said C-BEYOND enrolled patients in the U.S. and Canada, while C-FORWARD is enrolling patients across 17 countries outside North America. Combined, the two trials are expected to include more than 1,760 patients. 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. → 3 Small-Cap Stocks to Buy as the Russell 2000 Extends Its Rally In patients without cirrhosis, Atea’s regimen is administered for eight weeks, compared with 12 weeks for 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. Chief Development Officer Dr. Janet Hammond said data generated to date support what Atea views as a differentiated profile for bemnifosbuvir and ruzasvir, including high efficacy, shorter treatment duration, low risk for drug-drug interactions, dosing convenience and no food effect. Hammond said recent results demonstrate a low risk for drug-drug interactions with proton pump inhibitors, which she said are taken by an estimated at least 35% of HCV patients. She also said Atea has confirmed the absence of interaction with statins, another commonly prescribed medication class. The company plans to present additional data at the EASL meeting later this month. During the question-and-answer session, Sommadossi said the C-BEYOND top-line announcement will include the primary endpoint and key secondary efficacy endpoint, including sustained viral response at week 24 in both the modified intent-to-treat and per-protocol populations. Asked about the potential for superiority, Sommadossi said Atea’s Phase 3 program is designed for non-inferiority with a 5% margin. He added that a planned analysis combining the two Phase 3 studies has been shared with the U.S. Food and Drug Administration and could be used to evaluate potential superiority. Chief Commercial Officer John Vavricka said HCV remains a significant global health issue despite the availability of direct-acting antivirals. He cited company estimates that in the U.S., of 160,000 reported new chronic infections, about 85,000 patients are treated annually, and up to 4 million people are infected with HCV. Vavricka said the U.S. HCV market represents about $1.3 billion in annual net sales, or roughly half of the estimated $2.6 billion global market. He said healthcare providers have expressed support for a “test and treat” model in which testing, diagnosis and treatment initiation occur in a single setting, potentially reducing delays and patient drop-off. According to Vavricka, Atea’s payer research suggests a favorable outlook for access at parity net pricing across Medicaid, Medicare and commercial plans, subject to regulatory approval. He said an IQVIA study based on Phase 2 results found that 153 high-prescribing U.S. physicians indicated they would likely prescribe the regimen to approximately half of their patients, with similar results regardless of cirrhosis status. Vavricka said Atea believes it can pursue a capital-efficient commercial launch, noting that about 7,800 physicians write approximately 80% of direct-acting antiviral prescriptions. He said the company could reach most of the market with a specialty sales force of approximately 75 employees, including sales representatives, sales management and medical science liaisons. Atea is also advancing AT-587, a product candidate for chronic hepatitis E infection in immunocompromised patients. Sommadossi said chronic HEV can progress to cirrhosis within three to five years in this population, compared with a longer progression timeline often seen in hepatitis B or C. He said current management options include reducing immunosuppression and off-label ribavirin, both of which present challenges. Atea estimates that each year in the U.S. and Europe, 3% of approximately 450,000 patients with relevant underlying conditions are at risk of developing chronic HEV, representing a potential market opportunity of $750 million to $1 billion annually. Sommadossi said Atea has completed CTA-enabling studies for AT-587 and expects to initiate a first-in-human study in healthy volunteers around mid-year. The study will evaluate safety, tolerability and pharmacokinetics through a randomized, double-blind, placebo-controlled design with single-ascending and multiple-ascending dose phases. In response to an analyst question, Sommadossi said the multiple-ascending-dose portion of the Phase 1 study is expected to be seven days. He said Atea expects to begin a proof-of-concept study around year-end, likely starting with a 12-week treatment duration, while longer toxicology studies could support potential 24-week treatment if needed. Corcoran said first-quarter spending was principally directed toward the HCV program, completion of CTA-enabling studies for AT-587 and manufacturing of clinical trial material for the HEV candidate. Research and development expenses increased from the year-earlier quarter, driven mainly by higher external spending related to the Phase 3 HCV program and HEV preclinical development, partially offset by lower internal expenses. General and administrative expenses decreased due to lower salaries and wages, lower stock-based compensation and reduced professional fees. Corcoran said Atea intends to maintain financial discipline while preparing for regulatory filings, pre-launch activities and commercial launch supply manufacturing, with the “substantial majority” of 2026 spending focused on the hepatitis C program. Atea Pharmaceuticals, Inc is a clinical-stage biopharmaceutical company focused on the discovery and development of oral antiviral therapeutics targeting RNA viruses. The company's lead program, AT-527, is a direct-acting nucleotide prodrug licensed from Roche and is being evaluated as a potential treatment for coronavirus disease 2019 (COVID-19). In addition to its COVID-19 efforts, Atea's pipeline includes other small-molecule candidates for hepatitis C virus and emerging RNA pathogens, leveraging its proprietary nucleotide chemistry platform to address significant unmet medical needs in infectious diseases. Founded in 2014 and headquartered in Cambridge, Massachusetts, Atea operates research laboratories in the Greater Boston area and conducts clinical studies across North America, Europe and parts of Asia. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Atea Pharmaceuticals Q1 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for May 2026.

This article first appeared on GuruFocus. Release Date: May 12, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Atea Pharmaceuticals Inc (NASDAQ:AVIR) has completed patient enrollment for its North American trial with over 880 patients, representing diverse genotypes and demographics. The company is financially strong with $256 million in cash and marketable securities, ensuring the completion of its Phase 3 HCV program and advancement of the HEV development program. Atea's regimen for hepatitis C shows a potentially best-in-class profile with high efficacy, short treatment duration, and low risk for drug-drug interactions. The company is strategically expanding its antiviral pipeline to address unmet medical needs for immunocompromised patients with chronic hepatitis E infection. Atea's commercial strategy includes a capital-efficient launch with a focused sales force, leveraging a concentrated prescriber base for rapid market penetration. The global incidence of hepatitis C infections continues to rise, outpacing the number of patients being treated, highlighting a significant healthcare challenge. Most countries, including the U.S., are not on track to meet the World Health Organization's goal of HCV elimination by 2030. The company faces competition from established regimens like ICLUSA and MAVIRET, which have significant market presence. Atea's financial results show increased R&D expenses due to external spending on clinical development, which could impact profitability. The success of Atea's commercial launch is contingent on achieving favorable payer access and overcoming potential hurdles in integrating into test-and-treat initiatives. Warning! GuruFocus has detected 3 Warning Signs with AVIR. Is AVIR fairly valued? Test your thesis with our free DCF calculator. Q: What should we expect from the top-line announcements for CBeyond and C-Forward? What data will be included in the press release versus what will be reserved for later publication? A: We will release data for the primary endpoint and key secondary efficacy endpoint, specifically the SVR at week 24 after treatment initiation in both the modified intent-to-treat and per-protocol populations. Further details will be shared at medical meetings or in peer-reviewed settings. (Jean-Pierre Somodosi, CEO) Q: How will commercial adoption be affected by contracting or program requirements if the Phase III results confirm the differentiated product profile? A: Our launch preparations are underway, focusing on market analysis and understanding business segments. We are evaluating timelines and penetration strategies for Medicaid, Medicare, and commercial payers. Execution will begin upon receiving Phase III data. (John Vavrika, Chief Commercial Officer) Q: Based on Phase II results, what could impact prescriber or payer response in Phase III? A: We expect Phase III data to be consistent with Phase II, showing great efficacy and low potential for drug-drug interactions. Payers are particularly interested in the head-to-head trial results, which are crucial for launch readiness. (Rancha Horga, Chief Medical Officer) Q: Regarding the CBR trial, what is your confidence level in achieving a superiority claim based on SVR12 rates? A: Our goal is a non-inferiority trial within a 5% margin. We believe we have sufficient power for non-inferiority and will evaluate potential superiority by combining data from both trials. (Jean-Pierre Somodosi, CEO) Q: For the AT587 first-in-human study, what is the intended treatment duration, and what do you expect it to be in real-world settings? A: The first-in-human study will have a seven-day treatment duration. We anticipate a 12-week treatment duration for the proof-of-concept study, with flexibility to extend to 24 weeks if necessary. (Jean-Pierre Somodosi, CEO) For the complete transcript of the earnings call, please refer to the full earnings call transcript.

C-BEYOND Phase 3 North American Trial for Treatment of Hepatitis C Virus (HCV) Remains on Track with Topline Results Expected Mid-2026 C-FORWARD Phase 3 Trial Outside North America for Treatment of HCV on Track to Complete Enrollment Mid-2026; Topline Results Expected Around Year-End 2026 Encouraging Preclinical Data Support AT-587 as a Potential First-in-Class Therapy for Hepatitis E Virus (HEV); Phase 1 Initiation Expected Mid-2026 Company Holding Conference Call Today at 4:30 pm ET BOSTON, May 12, 2026 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (Atea or Company), a late-stage clinical biopharmaceutical company engaged in the discovery and development of oral antiviral therapeutics for serious viral diseases, today reported financial results for the first quarter ended March 31, 2026, and provided a business update. “With two pivotal Phase 3 readouts for our HCV program on the horizon, 2026 will be a catalyst-rich year for Atea,” said Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of Atea Pharmaceuticals. “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 low risk of drug-drug interactions, and dosing convenience. By simplifying HCV treatment for both patients and providers, our regimen preferentially aligns with the expanding ‘test-and-treat’ model of care, which we believe will result in more patients treated and an opportunity to accelerate HCV elimination efforts.” “In parallel, our HEV program underscores our continued commitment to developing antiviral therapeutics for serious viral diseases where significant unmet needs persist. HEV represents a critical gap in care with no approved therapies, leaving vulnerable populations including transplant recipients and other immunocompromised patients at risk for rapid disease progression. Following encouraging preclinical data, we look forward to advancing our potential first-in-class candidate, AT-587, into the clinic mid-year,” Dr. Sommadossi added. Approaching Pivotal Milestones in Phase 3 Program for Potential Best-in-Class HCV Regimen Atea continues to advance its global Phase 3 program for the treatment of chronic HCV infection. In the Phase 3 program, Atea is comparing the fixed-dose combination (FDC) regimen of bemnifosbuvir (BEM), a nucleotide analog polymerase inhibitor, and ruzasvir (RZR), an NS5A inhibitor, to the FDC regimen of sofosbuvir and velpatasvir. The regimen of BEM/RZR is administered orally once-daily for eight weeks (in patients without cirrhosis) or 12 weeks (in patients with compensated cirrhosis) while the regimen of sofosbuvir and velpatasvir is administered orally once-daily for 12 weeks to all patients, regardless of cirrhosis status. The global Phase 3 program consists of two open-label, controlled trials: C-BEYOND (conducted in North America): Enrollment completed in December 2025 with more than 880 patients; topline results expected mid-2026. C-FORWARD (conducted outside North America): Enrollment on track for completion mid-2026; topline results expected around year-end 2026. The primary endpoint for each trial is HCV RNA < lower limit of quantitation (LLOQ) at 24 weeks from the start of treatment and encompasses sustained virologic response 12 weeks post-treatment (SVR12) in each arm. Measurement at 24 weeks from the start of treatment is to ensure the primary endpoint measurement occurs at the same relative timepoint from the start of treatment in all patients. The primary endpoint will be assessed in the modified intent-to-treat population in C-BEYOND and in the per-protocol population in C-FORWARD. Results Support a Differentiated and Competitive Profile for the Treatment of HCV Results from Atea’s Phase 2 clinical study, together with results from other preclinical and clinical studies, continue to support a differentiated profile for BEM/RZR. In the Phase 2 study, the 8-week regimen achieved 98% SVR12 in the per-protocol, treatment-adherent population and 95% SVR12 in the efficacy-evaluable population. Additional preclinical and clinical studies have supported a high barrier to resistance, dosing convenience with or without food, co-administration with H2-blockers, a low risk of clinically meaningful drug-drug interactions, and no need for dose adjustment of BEM in patients with hepatic or renal impairment. Results from recent studies demonstrated a low risk of drug–drug interactions with proton pump inhibitors and statins. Atea notes this is particularly significant, as its market research indicates that up to 80% of patients infected with HCV take at least one concomitant medication with proton pump inhibitors and statins being among the most common. Last year, Atea presented data supporting a potentially differentiated antiviral mechanism of action. BEM has an established mechanism of inhibition of HCV RNA leading to chain termination, blocking viral production and replication inside the host cell. However, modeling of HCV viral kinetics from a Phase 1b study suggests that BEM may also inhibit the assembly/secretion of new HCV virions into the bloodstream. These data may further explain the high antiviral potency of BEM/RZR. Atea believes that collectively, these product attributes and study results position BEM/RZR competitively within the evolving HCV landscape. This is particularly relevant as the ‘test-and-treat’ model of care, which enables rapid diagnosis and treatment initiation at the point of care, is increasingly adopted by healthcare providers and supported by stakeholders as critical to HCV elimination efforts. HCV remains a significant global healthcare burden, affecting as many as four million people in the United States (US), according to the CDC. Preclinical Results Presented at the Conference on Retroviruses and Opportunistic Infections (CROI) 2026 Support AT-587 as a Potential First-in-Class Therapy for HEV In 2025, Atea strategically expanded its pipeline to target hepatitis E virus (HEV), for which no approved therapies currently exist. If successful, the HEV program could address a substantial unmet medical need for immunocompromised patients and other high-risk populations, such as transplant recipients, for whom HEV is a serious disease that can rapidly progress to cirrhosis. At CROI 2026, Atea presented in vitro data showing that two drug candidates, AT-587 and AT-2490, were potent inhibitors of HEV replication. The compounds were reported to be 30- to 150-fold more potent against HEV than either sofosbuvir or ribavirin, active against all flaviviruses tested as well as rubella and chikungunya, and associated with high levels of active metabolite formation in human liver cells. Neither compound showed toxicity in the reported studies. Atea selected AT-587 as the lead product candidate and anticipates initiating a Phase 1 clinical program for AT-587 in mid-2026. First Quarter 2026 Financial Results Cash, Cash Equivalents and Marketable Securities: $256.0 million at March 31, 2026, compared to $301.8 million at December 31, 2025. Research and Development Expenses: Research and development expenses increased by $11.6 million from $29.6 million for the three months ended March 31, 2025, to $41.1 million for the three months ended March 31, 2026. The net increase was partially driven by an increase in external spend for our HCV Phase 3 clinical development and HEV preclinical development. The increase was partially offset by lower internal research and development expenses primarily related to lower salaries and wages and lower stock-based compensation for the three months ended March 31, 2026. General and Administrative Expenses: General and administrative expenses decreased by $2.6 million from $9.5 million for the three months ended March 31, 2025, to $6.9 million for the three months ended March 31, 2026. The net decrease was primarily related to lower salaries and wages, lower stock-based compensation and lower professional fees for the three months ended March 31, 2026. Interest Income and Other, Net: Interest income and other, net, decreased by $2.4 million for the three months ended March 31, 2026, compared to the three months ended March 31, 2025, primarily due to lower investment balances. Income Taxes: Income tax expense was $0.1 million for the three months ended March 31, 2026, compared to $0.2 million for the three months ended March 31, 2025. Conference Call and Webcast Atea will host a conference call and live audio webcast to discuss first quarter 2026 financial results and provide a business update today at 4:30 p.m. ET. To access the live conference call, participants may register here. The live audio webcast of the call will be available under "Events and Presentations" in the Investor Relations section of the Atea website at ir.ateapharma.com. To participate via telephone, please dial 1-877-407-0779 (U.S.) or 1-201-389-0914 (International) and use conference ID number 13759581. An archive of the audio webcast will be available on Atea’s website approximately two hours after the conference call and will remain available for at least 90 days following the event. About Bemnifosbuvir and Ruzasvir for HCV BEM has been shown in in vitro studies to be approximately 10-fold more active than sofosbuvir (SOF) against a panel of laboratory strains and clinical isolates of HCV GT 1–5. In vitro studies have also demonstrated BEM remained fully active against SOF resistance-associated substitutions (S282T), with up to 58-fold more potency than SOF. The pharmacokinetic (PK) profile of BEM supports once-daily dosing for the treatment of HCV. BEM has been shown to have a low risk for drug-drug interactions. BEM has been administered to over 3,000 subjects and has been well-tolerated at doses up to 550 mg for durations up to 12 weeks in healthy subjects and patients. RZR has demonstrated highly potent and pan-genotypic antiviral activity in preclinical (picomolar range) and clinical studies. RZR has been administered to over 2,800 HCV-infected patients at daily doses of up to 180 mg for 12 weeks and has demonstrated a favorable safety profile. The PK profile of RZR supports once-daily dosing. About HCV HCV is a blood-borne, positive-sense, single-stranded RNA (ssRNA) virus that primarily infects liver cells. HCV is a leading cause of chronic liver disease and liver transplants, spreading via blood transfusion, hemodialysis and needle sticks, with approximately 240,000 deaths occurring each year. Despite the availability of DAAs, HCV continues to be a significant global healthcare issue. An estimated 50 million people worldwide are chronically infected with HCV and there are approximately one million new infections each year. In the US, as many as four million people are estimated to have HCV with annual new infections outpacing treatment rates. HCV infections in the US predominate in patients in the age group between 20 and 49 years old, and it is estimated that less than 10% of HCV-infected patients in the US have cirrhosis. Chronic HCV infection is a leading cause of liver cancer in the US, Europe and Japan. About HEV HEV is a positive sense, ssRNA virus which infects the liver and remains an under-recognized global health challenge with an estimated 20 million infections annually. Waterborne transmission of HEV genotypes 1 and 2 causes mostly acute self-limiting hepatitis in developing regions, whereas foodborne transmission of HEV genotype 3 predominates in the US and Europe and causes chronic hepatitis in immunocompromised patients, which can lead to cirrhosis in three to five years. There is a growing number of immunocompromised patients, a population that includes solid organ transplant and hematopoietic stem cell transplant recipients and patients with hematologic malignancies such as multiple myeloma. Each year, in the US and Europe, 3% of the approximately 450,000 patients who have these underlying medical conditions are at risk of developing chronic HEV. There is currently no approved antiviral therapy for HEV, and current off-label treatments have limited efficacy and tolerability, underscoring a clear and urgent unmet medical need. Atea’s initial HEV clinical efforts will focus on developing AT-587 for the treatment of immunocompromised patients with chronic HEV. About Atea Pharmaceuticals Atea is a late-stage clinical biopharmaceutical company focused on discovering, developing and commercializing oral antiviral therapies to address the unmet medical needs of patients with serious viral infections. Leveraging Atea’s deep understanding of antiviral drug development, nucleos(t)ide chemistry, biology, biochemistry and virology, Atea has built a proprietary nucleos(t)ide prodrug platform to develop novel product candidates to treat ssRNA, viruses, which are a prevalent cause of serious viral diseases. Atea plans to continue to build its pipeline of antiviral product candidates by augmenting its nucleos(t)ide platform with other classes of antivirals that may be used in combination with its nucleos(t)ide product candidates. Atea’s Phase 3 program is evaluating the FDC regimen of BEM, a nucleotide analog polymerase inhibitor, and RZR, an NS5A inhibitor, to treat HCV. Atea anticipates initiating clinical development of AT-587, a nucleotide analog, for the treatment of HEV in mid-2026. For more information, please visit www.ateapharma.com. Forward-Looking Statements This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include but are not limited to statements regarding the potential best-in-class profile of the BEM/RZR regimen for the treatment of HCV, the potential opportunity to advance efforts to eradicate HCV, the potential to develop a product for the treatment of HEV, anticipated milestone events and timelines for clinical trials including the timeline for readout of the HCV Phase 3 clinical trials results and initiation of the HEV clinical development, future results of operations and business strategy. When used herein, words including “expected,” “should,” “anticipated,” “believe,” “will,” “plans”, and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Atea’s current expectations and various assumptions. Atea believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Atea may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, uncertainties inherent in the drug discovery and development process and the regulatory submission or approval process, unexpected or unfavorable safety or efficacy data or results observed during clinical trials or in data readouts; delays in or disruptions to clinical trials or our business; our reliance on third parties over which we may not always have full control; our ability to manufacture sufficient commercial product; competition from approved treatments for HCV; dependence on the success of Atea’s most advanced product candidates, in particular the BEM/RZR regimen for the treatment of HCV; as well as the other important factors discussed under the caption “Risk Factors” in Atea’s Annual Report on Form 10-K for the year ended December 31, 2025 as such factors may be updated from time to time in its other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. All forward-looking statements represent management’s estimates as of the date of this press release. While Atea may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause our views to change. Forward-looking statements should not be relied upon as representing Atea’s views as of any date subsequent to the date of this press release. Contacts Jonae Barnes SVP, Investor Relations and Corporate Communications 617-818-2985 [email protected] Joyce Allaire LifeSci Advisors [email protected]