管理層發言
Ladies and gentlemen, thank you for standing by. Welcome to Atea Pharmaceuticals' First Quarter 2026 Earnings Conference Call. At this time, participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. I will now turn it over to Atea's management team. Please go ahead.
Hi, thank you, operator. Good afternoon, everyone, and welcome to Atea Pharmaceuticals' first quarter 2026 Financial Results and Business Update Conference Call. Earlier today, we issued a press release which outlines the topics we plan to discuss. You can access the press release as well as the slides that we will be reviewing today by visiting the Investors section of our website at ir.ateapharma.com. With me today from Atea are our Chief Executive Officer and Founder, Dr. Jean-Pierre Sommadossi; Chief Development Officer, Dr. Janet J. Hammond; Chief Commercial Officer, John F. Vavricka; Chief Medical Officer, Dr. Maria Arantxa Horga; and Chief Financial Officer and Executive Vice President of Legal, Andrea J. Corcoran, who will all be available for the Q&A portion of today's call. Before we begin the call, and as outlined on Slide 2, I would like to remind you that today's discussion will contain forward-looking statements that involve risks and uncertainties. These risks and uncertainties are outlined in today's press release and in the company's recent filings with the Securities and Exchange Commission, which we encourage you to read. Our actual results may differ materially from what is discussed on today's call. With that, I will now turn the call over to Jean-Pierre.
Thank you, Jonae. Good afternoon, everyone, and thank you for joining us. I will begin on Slide 3. With two pivotal Phase 3 topline readouts for our global Phase III HCV program ahead of us, 2026 will be a catalyst-rich year for Atea. We remain on track and are very encouraged by the substantial progress our team continues to achieve. We completed patient enrollment for C-BEYOND, our North American trial, late last year with over 880 patients who are representative of the genotypes and demographics in North America. For C-FORWARD, our ex-North America trial, I am pleased to share today that we have completed enrollment for 95% of the cirrhotic and non-cirrhotic patients and anticipate completing enrollment next month as scheduled. Currently, enrollment is only open to the less prevalent genotypes such as 4, 5, and 6, which will allow us to support a broad label. This sets up two important Phase 3 milestones. We expect topline data from C-BEYOND mid-year as we have reported before and topline data from C-FORWARD around year-end. Late last year, we expanded our antiviral hepatitis pipeline to address a major unmet medical need for immunocompromised patients living with chronic hepatitis E infection, a liver disease for which there is currently no approved therapy. If left untreated in this at-risk population, it can rapidly progress to cirrhosis within only three to five years. We have completed CTA-enabling studies for AT-587, our lead product candidate, and we anticipate initiating a first-in-human study mid-year. Initial results were presented in February at CROI 2026 and additional data will be presented at EASL later this month to support AT-587 as a potential first-in-class inhibitor against hepatitis E infection. I will review this exciting program and our clinical plan for the first-in-human study later in this presentation. Importantly, with $256 million of cash, cash equivalents and marketable securities as of March 31, 2026, we are in a strong financial position to execute and complete our Phase III HCV program and advance our new HEV development program. We anticipate our cash runway remaining through 2027. With that, I will now turn the call over to Janet to review the profile of our regimen.
Thanks, Jean-Pierre. On Slide 5, we are conducting the first active-controlled Phase 3 global program for hepatitis C, comparing our regimen against the current standard of care, sofosbuvir and velpatasvir, which is marketed as Epclusa. The data generated to date for the regimen of bemnifosbuvir and ruzasvir supported a differentiated, potentially best-in-class profile, combining high efficacy, short treatment duration with a low risk for drug interactions, dosing convenience, and no food effect. We continue to add to our dataset and recent results demonstrate a low risk for drug interaction with proton pump inhibitors, which are taken by an estimated at least 35 percent of hepatitis C patients. We have also confirmed the absence of an interaction with HMG-CoA reductase inhibitors, or statins, another important and commonly prescribed class of medication. In closing, I am also pleased to share that we will be presenting additional results at EASL later this month that support the potential for a best-in-class profile for our regimen. I am going to hand the call over now to Arantxa to review our Phase 3 program for the treatment of hepatitis C. Arantxa?
Thank you, Janet. Moving to Slide 7, as a reminder, C-BEYOND enrolled patients in the U.S. and Canada and C-FORWARD is enrolling patients in 17 countries outside of North America. Combined, we expect to enroll more than 7,700 patients in our Phase 3 program. Both trials are open-label, randomized 1 to 1 against the active comparator and stratified by cirrhosis status and genotype, including patients coinfected with HIV. In patients with cirrhosis, treatment duration is eight weeks with bemnifosbuvir/ruzasvir and 12 weeks with the standard of care. Patients with compensated cirrhosis receive 12 weeks of treatment with either regimen. The primary endpoint for both studies is sustained virologic response, or SVR, 24 weeks after treatment initiation. Slide 8 shows that the geographic footprint of our global Phase III program is comprised of approximately 120 clinical sites in the U.S. and Canada for C-BEYOND and 120 clinical sites in 17 countries outside of North America for C-FORWARD. We completed patient enrollment of our C-BEYOND trial in December with more than 880 patients and we anticipate topline results mid-year. C-FORWARD has a broader global geographic and genotypic footprint, and we expect to complete enrollment mid-year and to report topline results around year-end. As J.P. mentioned earlier, we are pleased to share that for C-FORWARD, we have completed enrollment of 95% of the trial in cirrhotic and non-cirrhotic patients. Enrollment is only open to the less frequent genotypes such as 4, 5, and 6, which will support a broad label. Enrollment of C-FORWARD remains on track to be completed by mid-year. On Slide 9, let's review the Phase 3 endpoints, patient population and data analysis for our global Phase III program. In C-BEYOND, the primary endpoint will be analyzed in a modified intent-to-treat, or MITT, population as preferred by the U.S. FDA. The analysis will include patients that have been randomized and dosed regardless of drug adherence or loss to follow-up. The statistical analysis will be based on an imputation model with success or failure depending on PCR value, whether negative or not, prior to patient treatment discontinuation. A key secondary endpoint will be the SVR rate in the per-protocol population. In C-FORWARD, the per-protocol population will be analyzed as the primary endpoint as preferred by the EMA, and the SVR rate will only include patients who are at least 80% adherent as measured by pill count and have an SVR assessment at week 24. A key secondary endpoint will be the SVR rate in the MITT population. The same methods for assessing non-inferiority will be conducted in both Phase 3 studies and in both patient populations. The Phase 3 studies are powered 90% with a 5% non-inferiority margin with expected rates of about 95% in the modified intent-to-treat population. Using these two approaches in a post hoc analysis of the Phase 2 results, the SVR rate was 95% in the MITT population and similar in the per-protocol population. I will now hand the call over to John Vavricka, our Chief Commercial Officer. John?
Thank you, Arantxa. I will begin on Slide 11. HCV remains a significant global healthcare crisis, with an increasing incidence of infections despite the availability of direct-acting antivirals for the past decade. Currently in the U.S., out of a reported 160,000 new chronic infections, only approximately 85,000 patients are treated annually. In the U.S., it is estimated that up to 4 million people are infected with HCV. The unrelenting high rate of new chronic HCV infections, which continues to outpace the number of patients being treated, underscores the need for a new differentiated and optimized therapy. Most countries worldwide, including the U.S., are not on track to achieve the World Health Organization's goal of HCV elimination by 2030. In fact, current estimates suggest we may not even achieve this goal by 2050. HCV is also a leading driver of liver-related morbidity in the U.S., including progression to cirrhosis and liver cancer, reinforcing the importance of expanding diagnosis and treatment. Moving to Slide 12, the U.S. HCV market remains substantial with approximately $1.3 billion in annual net sales, about 50% of the roughly $2.6 billion global market, reflecting the size of the opportunity. In our discussions with healthcare providers, we consistently hear that a point-of-care test-and-treat approach where testing, diagnosis, and treatment initiation occur in a single setting can significantly reduce delays in care and minimize patient drop-off before treatment begins. This model has broad support including from the CDC, and is gaining momentum through bipartisan efforts to achieve HCV elimination in the U.S. Key opinion leaders believe it can be an important lever to help increase the number of patients treated and support HCV elimination efforts, and they continue to emphasize the need for therapy designed to integrate smoothly into this care pathway. Let's turn to Slide 13. This slide summarizes the U.S. HCV payer mix and expected access dynamics. Medicaid represents just over half of DAA volume, with Medicare and commercial plans accounting for the balance. On the right, payer research shows a favorable outlook for parity access and parity net pricing across all three segments with meaningful concentrations of Medicare, Medicaid, and commercial payers indicating they would be very likely to add another option. Overall, these data support our view that BEM-RZR could achieve broad formulary inclusion subject to regulatory approval. Slide 14 highlights the competitive positions for the U.S. HCV market today. You can see that Epclusa and Mavyret drive value from different payer mixes, with Epclusa skewing more heavily towards Medicare and Mavyret concentrated in Medicaid. On Slide 15, using our Phase 2 results, IQVIA conducted an independent quantitative market research study with 153 U.S. high prescribers. These physicians indicated that they would likely prescribe the BEM-RZR regimen to approximately half of their patients, and the results were similar for all patients regardless of their cirrhosis state. On Slide 16, based on the U.S. HCV market dynamics, we believe we can be well positioned for a capital-efficient commercial launch. The prescriber base is highly concentrated; roughly 7,800 physicians write about 80% of all DAA prescriptions. We can reach the vast majority of the market with a specialty sales force of approximately 75, including sales representatives, sales management, and medical science liaisons. With no other candidates in late-stage clinical development, BEM-RZR enters a market primarily served by only two regimens. On the supply side, all components and processes for large-scale manufacturing are in place, and the commercial supply production is already underway, with a low cost of goods relative to expected net pricing. The four-week dosing blister card packaging supports patient convenience and adherence. Taken together, we believe the concentrated prescriber base, focused commercial infrastructure, and favorable manufacturing economics position us for a short time to profitability following NDA approval. I will now hand the call back to Jean-Pierre to review the HEV program.
Thank you, John. Let's move to Slide 18. Hepatitis E virus, or HEV, is an acute and chronic liver disease. In developing countries, genotypes 1 and 2 are most prevalent and the virus is transmitted primarily through contaminated water, leading to epidemics of acute, self-limited viral hepatitis. In developed countries, mostly the U.S. and Europe, genotype 3 is the most prevalent and is primarily transmitted through contaminated food such as undercooked meat. This genotype can cause chronic hepatitis in immunocompromised patients which can progress to cirrhosis within a short time of three to five years. As you may know, this is far more aggressive than what occurs with hepatitis C or hepatitis B where progression often takes 15 to 20 years or even longer. Moving to Slide 19, in recent years, with the increasing number of patients who are immunocompromised, including solid organ transplant recipients, hematopoietic stem cell transplant recipients, as well as patients with hematologic malignancies such as multiple myeloma, there has been a growing incidence of chronic hepatitis E infection in the U.S. and Europe. Currently, the standard of care includes reducing immunosuppression and/or off-label administration, which both present challenges, leading to a real opportunity for an effective direct-acting antiviral drug. On Slide 20, each year in the U.S. and Europe, approximately 3% of the roughly 450,000 patients who have these underlying medical conditions are at risk to develop chronic hepatitis E. The unmet need for this patient population potentially represents a market opportunity between $750 million to $1 billion each year. On Slide 21, this slide highlights the preclinical data for AT-587 as a potential first-in-class direct-acting antiviral for chronic hepatitis E. In the genotype 3 replicon in vitro model, AT-587 demonstrated the greatest potency and importantly, this antiviral activity has also been confirmed in primary human hepatocytes, the target organ for hepatitis E replication. In vitro data also indicates low potential for drug interaction, which is important for this patient population who often take lifelong therapies. On Slide 22, today AT-587 has a clean in vitro and in vivo safety profile. CTA-enabling GLP toxicology and safety pharmacology studies are completed, allowing us to advance to Phase 1 studies and positioning this product candidate as a first-in-class direct-acting antiviral for chronic hepatitis E infections. On Slide 23, the in vitro and nonclinical PK data in nonhuman primates and PBPK modeling indicate we can predict that plasma exposure in humans will exceed the in vitro EC50 against hepatitis E replication across the intended administration at pharmacologically relevant dosing. On Slide 24, this slide outlines a synopsis of our first-in-human study for AT-587. The study will be conducted in healthy 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. We have incorporated standard sentinel dosing and gated escalation with dose progression informed by real-time safety and PK review. The study includes both single ascending and multiple ascending dose phases, providing flexibility to refine dose levels as data emerge. I will now turn the call over to Andrea to discuss Atea's financials.
Thank you, Jean-Pierre. As Jonae mentioned in her introductory remarks, earlier today, we issued a press release containing our financial results for the first quarter 2026. The statement of operations and balance sheet are on Slides 26 and 27. We are pleased to report that our cash and investments were $256 million at March 31, 2026. The funds expended in the first quarter were principally directed to the advancement of our HCV program, evaluating the combination regimen of bemnifosbuvir and ruzasvir, and to the advancement and completion of the CTA-enabling studies and manufacture of clinical trial material for AT-587, our product candidate for the treatment of HEV. For R&D expenses, quarter-over-quarter there was an increase in 2026 compared to 2025. The net increase in 2026 was principally driven by an increase in external spend related to our HCV Phase III clinical development and HEV preclinical development, offset by lower internal expenses primarily related to a decrease in stock-based compensation and lower payroll and payroll-related expenses. For G&A, quarter-over-quarter expenses decreased. The net decrease was primarily related to lower salaries and wages, lower stock-based compensation expense, and lower professional fees. In 2026, we intend to maintain our rigorous financial discipline while remaining laser-focused on execution and value-creating advancement of our HCV and HEV product candidates. As we complete our Phase III trials, prepare to submit our regulatory filings and engage in prelaunch activities including the manufacturing of commercial launch supply, the substantial majority of our spending in 2026 will remain focused on the advancement of our hepatitis C program. With the resources in hand at the end of March, we expect to realize value-creating milestones for both our hepatitis C and our hepatitis E programs and we project our cash runway to extend through 2027. I will now hand the call back to Jean-Pierre for closing remarks.
Thank you, Andrea. In closing, 2026 is set to be a pivotal and value-creating year for Atea. We remain on track to deliver topline Phase III results from C-BEYOND in mid-2026, followed by topline Phase 3 results from C-FORWARD around year-end. We believe the target profile of our regimen—high efficacy, short treatment duration, a low risk of drug interaction, and convenient dosing with no food effect—position us to meaningfully address the needs of today's patients and prescribers. We believe our regimen fits seamlessly within the test-and-treat model of care which has the potential to expand the number of patients treated and accelerate progress toward the goal of HCV elimination in the United States and globally. Our HEV program is a strategic expansion of our antiviral pipeline aimed at addressing a major unmet need for a highly vulnerable patient population with no approved treatment options today. We anticipate initiating our first-in-human study mid-year followed by the initiation of a proof-of-concept study around year-end. With that, I will turn the call back to the operator.
分析師問答
Thank you. At this time, we will be conducting a question-and-answer session. It may be necessary to pick up your handset before pressing the star key. Our first question is from Jonathan Miller with Evercore.
Hi, guys. Thanks so much for taking my question and looking forward to the upcoming data. Let's start with that. I guess to what extent or what should we expect from the topline announcements for C-BEYOND and then later in the year for C-FORWARD? What sorts of data should we expect in a topline press release versus what would be withheld for later publication at a medical meeting or a peer-reviewed setting? And then second, when we think about commercial launch cadence and potential there, assuming the Phase 3s bear out the differentiated product profile that you guys have been telling us about for a while, to what extent is commercial adoption going to be gated by contracting or by lumpy elements of getting your regimen in place in a program or a test-and-treat initiative that might have requirements on the drug it chooses?
Thank you, Jon. I will address the first question. For C-BEYOND we will release data on the primary endpoint and the key secondary efficacy endpoint: the SVR at week 24 after initiation of treatment in the modified intent-to-treat population, as well as the SVR at week 24 in the per-protocol population. John, do you want to address the second part of the question?
Sure. Jon, thank you for the question. Currently, our launch preparations are underway and that includes market analysis and evaluation of where business segments are coming from, where likely future growth will be coming from, and where we will focus our activities. That includes targeting across the three payer segments and understanding their formulary status and associated timelines, as well as preparations for Medicaid and Medicare. We will start executing these activities upon the data from our Phase 3 trials. In terms of timelines and contracting dynamics, we'll be evaluating all of that as part of our launch readiness and penetration segmentation for the market.
Thank you.
Our next question is from Maxwell Skor with Morgan Stanley.
Hello. This is Selena Zhang on for Maxwell Skor. Thanks for taking our question. With your market research based on Phase II results, what could you see in Phase III that you would expect to impact prescriber or payer response? What might change between Phase II and Phase III that could impact prescriber or payer behavior?
So I think we see trends similar to what we found in Phase 2, which is great efficacy with low potential for drug interaction and no food effect. Data from Phase 2 in infectious diseases often translates well into Phase 3. John, do you want to add something?
No, I think I'm fine. The Phase 2 data was very well received. One additional point is that payers and other stakeholders are also very interested in having a head-to-head trial, because it is the first time we've done that versus the standard of care. That head-to-head aspect is intriguing and important to them and plays into launch readiness and payer conversations.
Thank you.
Our next question is from Andy Hsieh with William Blair.
First one has to do with C-BEYOND. Looking at the modified intent-to-treat population analysis plan, I think you basically calculated an SVR of 95% based on the Phase 2 study. Looking across the landscape, I believe Gilead published some of the noncompliant SVR12 rates before and it is in the low nineties depending on the trials you look at. So I'm curious about your thinking in terms of a superiority claim based on that delta, coming out of the powering and sample size to see what level of confidence you have to achieve that milestone. Second question has to do with AT-587. You mentioned the first-in-human study and the design. Two parts: for this first-in-human study, what is the treatment duration that you intend to test? And then, in the real-world setting, what do you expect the treatment duration to be? Thank you.
That's a great question. Our goal is to deliver a regimen to patients and prescribers with the attributes we've demonstrated in clinical and nonclinical studies and clinical pharmacology. Our goal for the Phase 3 program is to demonstrate non-inferiority within a 5% margin. When we look at real-world true intent-to-treat, you are correct that rates for Epclusa can be around 90% in practice; in our Phase 2 we observed similar real-world intent-to-treat performance. We don't want to speculate; we will evaluate the data. We believe we have sufficient power for the non-inferiority target. We may observe superiority when combining the two trials, and there is a planned analysis that has been shared with the FDA to evaluate potential superiority by combining the studies. Regarding AT-587, for Phase 1 the multiple ascending dose portion will include a seven-day MAD as a typical Phase 1 design. For the proof-of-concept study, which we expect to initiate by year-end, we are planning a 12-week treatment duration. We have chronic toxicology studies ongoing and expect to complete those in time to open the proof-of-concept. Based on our predictions and early modeling, a 600-milligram dose is a potential human dose, either once daily or twice daily; we'll determine that based on the Phase 1 PK and safety. The proof-of-concept will likely be 12 weeks. If necessary, given results, we could extend to 24 weeks for the patient population. Treatment duration is not a significant constraint in this population since these patients often take lifelong immunosuppression and compliance is expected to be good. From preclinical safety we see a favorable profile and the Phase 1 will give us flexibility to decide QD versus BID and whether 12 or 24 weeks is appropriate.
Thank you. We have reached the end of the question-and-answer session. I would like to turn the call back to Jean-Pierre Sommadossi for closing remarks.
Thank you all for joining our first quarter 2026 earnings conference call, and thank you for your continued support.
Thank you. This concludes today's conference. You may disconnect your lines at this time. Have a wonderful day.