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.