Atea Pharmaceuticals Q1 2026 Earnings Call: Complete Transcript

Atea Pharmaceuticals ( AVIR ) held its first-quarter earnings conference call on Tuesday. Below is the complete transcript from the call. This content is powered by Benzinga APIs. For comprehensive financial data and transcripts, visit https://www.benzinga.com/apis/. The full earnings call is available at https://viavid.webcasts.com/starthere.jsp?ei=1757740&tp_key=b853d5ec64 Summary Atea Pharmaceuticals ( AVIR ) reported a strong financial position with $256 million in cash and equivalents, projecting a cash runway through 2027. The company is progressing with its global Phase 3 HCV program, having completed enrollment in North America and nearing completion outside North America, with anticipated top-line data releases mid-year and year-end. Atea Pharmaceuticals ( AVIR ) expanded its pipeline to include a new HEV program, planning to initiate a first-in-human study mid-year, targeting an unmet need in immunocompromised patients. Phase 2 data suggests a potential best-in-class profile for its HCV regimen, with high efficacy and low risk of drug interactions, which could support a strong position in the $2.6 billion global HCV market. Management emphasized strategic positioning for a commercial launch in the HCV market, leveraging a concentrated prescriber base and favorable payer dynamics. Full Transcript OPERATOR Ladies and gentlemen, thank you for standing by. Welcome to Atea Pharmaceuticals' ( AVIR ) first quarter 2026 earnings conference call. At this time, all participants are in a listen only mode. A brief question and answer session will follow the formal presentation. If you should require operator assistance during the conference, please press Star 0 on your telephone keypad. I will now turn it over to the Atea management team. Please go ahead. Jonae Hi, thank you operator. Good afternoon everyone and welcome to Atea Pharmaceuticals First Quarter 2026 Financial Results and Business Update Conference Call. Earlier today we issued a press release which outlines the topics we plan to discuss. You can access the press release as well as the slides that we'll be reviewing today by visiting the Investor section of our website at ir.ateapharma.com. With me today from ATEA are our Chief Executive Officer and Founder, Dr. Jean Pierre Samidosi, Chief Development Officer, Dr. Janet Hammond, Chief Commercial Officer John Vavrika, Chief Medical Officer, Dr. Arancha Horga and Chief Financial Officer and Executive Vice President of Legal, Andrea Corcoran, who will all be available for the Q and 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 risk and uncertainties. These risks and uncertainties are outlined in today's press release and in the Company's recent filings with the Securities and Exchange Commission, which we encourage you to read. Our actual results may differ materially from what is discussed on today's call. With that, I'll now turn the call over to Jean Pierre. Jean Pierre Thank you Jonae. Good afternoon everyone and thank you for joining us. I will begin on slide 3 with two pivotal phase 3 top line readouts for our global phase 3 HCV program. Ahead of us, 2026 will be catalyst 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 CBeyond, our North American trial, late last year with over 880 patients who are representative of the genotypes and demographics in North America for C Forward, our EX North America trial. I'm pleased to share today that we have completed enrollment for 95% of the cirrhotic and non cirrhotic patients and anticipate to complete enrollment next month as scheduled. Currently, enrollment is only open to the less prevalent genotypes such as 4, 5 and 6, which will allow us to support a broad label. This set up two important Phase 3 Milestones we expect top line data from CBR in mid year as we have reported before and top line data from CForward 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 AT587, our lead product candidate and we anticipate to initiate a first in human study mid year. Initial results were presented in February at Croi 2026 and additional data will be presented at EASIL later this month to support AT-587 as a potential first in class inhibitor against hepatitis E infection. I will review this exciting program and our clinical plan for a first in human study later in this presentation. Importantly, with 256 million in cash, cash equivalent and marketable securities as of March 31, 2026, we are in strong financial position to execute and complete our Phase 3 HCV program and advance our new HEV development program. We anticipate our cash Runway remaining through 2027. With that, I will now turn the call over to Janet to review the profile of our regimen. Janet Thanks Jean Pierre on slide 5 we are conducting the first active controlled phase 3 global program for hepatitis, comparing our regimen against the current standard of care, the sofosbuvir and velpatasvir, which is marketed as epclusa. The data generated to date for the regimen of bemifosbuvir and ruzasvir support a differentiated potentially best in class profile combining high efficacy, short treatment duration with a low risk for drug drug interactions, dosing convenience and no food effect. We continue to add to our data set and recent results demonstrate a low risk for drug drug interactions with proton pump inhibitors which are taken by estimated at least 35% of hepatitis C patients. We've also confirmed the absence of an interaction with HMG CoA Reductase inhibitors or statins, another important and commonly prescribed class of medications. In closing, I'm also pleased to share that we will be presenting additional results at EASL later this month that support the potential for a best in class profile for our regimen. I'm going to hand the call over now to Arantia to review our Phase three program for the treatment of hepatitis Arantha C. Arantha thank you Janet. Moving ahead to Slide 7. As a reminder, see beyond enrolled patients in the US and Canada and CForward is enrolling patients in 17 countries outside of North America. Combined, we expect to enroll more than 1,760 patients in our phase 3 program. Both trials are open label, randomized one to one against the active comparator and stratified by cirrhosis status and genotype including patients CO infected with HIV. In patients with cirrhosis, treatment duration is 8 weeks with beniphosphovirusvir and 12 weeks with the standard of care. Patients with compensated cirrhosis received 12 weeks of treatment with either regimen. The primary endpoint for both studies is sustained viral response or cure 24 weeks after treatment initiation. Slide 8 shows that the geographic footprint of our global Phase 3 program was comprised of approximately 120 clinical sites and in the US and Canada for C beyond and another 120 clinical sites in 17 countries outside of North America. For C Forward, we completed patient enrollment of our CBeyond trial in December with more than 880 patients and we anticipate top line results mid year. C Forward has a broader global geographic and genotypic footprint and we expect to complete enrollment mid year and to report top line results around year end. As JP mentioned earlier, we are pleased to share that for See 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 3 program in Cbeyond, the primary endpoint will be analyzed in a modified Intent to Treat or mITT population as preferred by the US fda. The analysis will include patients that have been randomized and those regardless of drug adherence or loss to follow up. The statistical analysis will be based on an imputation model with success or failure depending on PCR value, whether negative or not prior to patient treatment discontinuation. A key secondary endpoint will be the SBR rate in the per protocol population. In C Forward, the per protocol population will be analyzed as the primary endpoint as preserved by the ema, and the SVR rate will only include patients who are at least 80% adherent as measured by pill count and have an SVR assessment at week 24. A key secondary endpoint will be the SVR rate in the mITT population. The same 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 5% non inferiority margin with expected rates about 95% in a modified Intent to Treat or MIT population. Using these two approaches, in a post hoc analysis of the phase two results, the SVR rate was 95% 90% in the per protocol population. I will now hand the call over to John Pabrika, our Chief Commercial Officer. John Pabrika John thank you Arantia. I'll begin on slide 11. HCV remains a significant global healthcare crisis with an increasing incidence of infections despite the availability of direct antivirals for the past decade. Currently in the U.S. out of a reported 160,000 new chronic infections, only approximately 85,000 patients are treated annually in the U.S. it's estimated that up to 4 million people are infected with HCV. The unrelenting high rate of new chronic HCV infections, which continues to outpace the number of patients being treated, underscores the need for a new differentiated and optimized therapy. Most countries worldwide, including the US 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 US including progression to cirrhosis and liver cancer, reinforcing the importance of expanding diagnosis and treatment. Moving to Slide 12 the US 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 US 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 US HCV payer mix and expected access dynamics. Medicaid represents just over half of DAA volume, with Medicare and commercial plans accounting for the balance on the right payer. Research shows a favorable outlook for parity access at parity net pricing across all 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 FEM or ZR could achieve broad formulary inclusion subject to regulatory approval. Slide 14 this slide highlights the competitive positions for the US HCV market today. You can see that Iplusa and Naviret derive value from different payer mixes. IPLUSA is skewing more heavily towards Medicare by Mavuret is concentrated in Medicaid. Let's move to Slide 15. Using our Phase 2 results, IQVIA conducted an independent quantitative market research study with 153 US high prescribers. These physicians indicated that they would likely prescribe BAMR's the Aura regimen to approximately half of their patients and the results were similar for all patients regardless of their cirrhosis state. On slide 8. Based on the US HCD market dynamics, we believe we can be well positioned for a capital efficient Commercial launch prescriber base is highly concentrated. Roughly 7,800 physicians write about 80% of all DAA prescriptions. 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, MRZR enters the market primarily served by only two regiments. On the supply side, all components and processes for large scale manufacturing are in place and the commercial launch supply production is already underway with a low cost of goods relative to expected net pricing. The 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 of profitability. Following NDA approval, I will now hand the call back to Jean Pierre to review the HEV program. Jean Pierre Thank you John. Let's move to slide 18. Hepatitis E Virus, or HEV is an acute and a chronic liver disease in developing countries. Genotypes 1 and 2 are most prevalent and the virus is transmitted primarily through contaminated water, leading to epidemics of acute self limiting viral hepatitis in developed countries and mostly US 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. And as you may know, this is far more aggressive than what's occurred with Hepatitis C or Hepatitis B where it takes 15 to 20 years or even longer. Moving to slide 19 in recent years, with the increasing number of patients who are immunocompromised, including solid organ transplant recipients, hematopoietic stem cell transplant recipients as well as patients with hematologic malignancies such as multiple myeloma. There have been a growing incidence of chronic hepatitis C infection in US and Europe. Currently the standard of care include reducing immunosuppression and or off label ribavirin administration which both present challenges leading to a real opportunity for an effective direct antiviral drug. On slide 20 each year in US and Europe 3% of approximately 450,000 patients who have this underlying medical condition are at risk to develop chronic hepatitis E. The unmet need for this patient population potentially represent a market opportunity between $750 million to a billion dollars each year. On slide 21 this slide highlights the preclinical data for 8587 as a potential first in class direct acting antiviral for chronic hepatitis e in the genotype 3 replicant in vitro model AT-587 demonstrate the greatest potency and importantly this antiviral activity has also been confirmed in primary human hepatocytes, the target organ for hepatitis E replication. In vitro data also indicate low potential for drug drug interaction which is important for this immunocompromised patient who for some take lifelong therapies. On slide 22 today at 587 as 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 one studies and positioning this product candidate as a first in class direct acting antiviral for chronic hepatitis E infections. On slide 23 the PK data in non human primates and zoom modeling. We can predict that plasma exposure in humans will exceed the in vitro EC50 against hepatitis E replication in vitro across the internal administration at pharmacologically relevant dosing on slide 24. This slide outlines a synopsis of our first in human study for AT-587. The study will be conducted in Healthy volunteer with the primary objectives of evaluating safety, tolerability and pharmacokinetics. It's a randomized double blind placebo-controlled design with sequential dose escalation and an embedded 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 Andrea to Andrea to discuss ATEA financials. Thank you Jean Pierre. As Jonae mentioned in her introductory remarks earlier Today we issued a press release containing our financial Results for the first quarter 2026 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 beniphosphvir and rucasvir and to the advancement and completion of the CTA enabling studies and manufacture clinical trial material of at 587 our product candidate for the treatment of HEV for R and D expenses Quarter over quarter there was an increase in 2026 compared to 2025. The net increase in 26 was principally driven by an increase in external spend related to our HCV phase III clinical development and HEV preclinical development offset by lower internal expenses primarily related to a decrease in stock based compensation and lower payroll and payroll related expenses for G and 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 three trials, prepare to submit our regulatory filings and engage in prelaunch activities including the manufacturing of commercial launch supplied. A substantial majority of our spending in 2026 will remain focused on the advancement of our Hepatitis C program. With the resources in hand at the end of March, we expect to realize value creating milestones for both our Hepatitis C and our Hepatitis E programs and we project our cash Runway to extend through 2027. I'll now hand the call back to Jean Pierre for closing remarks. Jean Pierre Thank you Andrea. In closing, 2026 is set to be a pivotal and value creating year for ATEA. We remain on track to deliver top line phase three result from CBR in mid-2026 followed by top line phase three results from C forward around end of the year. We believe the drug profile of our regimen, high efficacy, short treatment duration, a low risk of drug drug interaction and convenient dosing with no food effect position us to meaningfully address the needs of today patients and prescribers. We believe our regimen fits seamlessly with within the test and treat model of care which has the potential to expand the number of patients treated and accelerate progress toward the goal of HCV eradication in the United States and globally. Our HEV program is a strategic expansion of our antiviral pipeline aimed at addressing a major unmet need for highly vulnerable patient population with no approval treatment options. Today we anticipate initiating our first inhuman study mid year, followed by the initiation of a proof of concept study around year end. With that I will turn the call back over to the operator. OPERATOR Thank you. At this time we will be conducting a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. Confirmation tone will indicate your line is in the question queue. If you'd like to remove your question from the queue, please press star2. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Our first question is from Jonathan Miller with Evercore. Jonathan Miller Hi guys. Thanks so much for taking my question and looking forward to the upcoming data. Let's start with that I guess to what extent or what should we expect from the top line announcements for C beyond and then later in the year for C forward, what sorts of data should we expect in a top line press release versus what would be withheld for later publication at a medical meeting or in a peer reviewed setting? So A and then second, when we think about commercial launch cadence and potential there, assuming the Phase 3s bear the differentiated product profile that you guys have been telling us about for a while, to what extent is commercial adoption going to be gated by contracting or by lumpy elements of getting your regimen in place in a program or a test to treat initiative that might have requirements on the drug that chooses? Jean Pierre Thank you John. Okay, I will address the first question. The first question we will release as data with the CBR the primary endpoint and the key secondary efficacy endpoint. So the SVR at week 24 after initiation of treatment in the modifying 10 to T population as well as the SVR week 24 in the protocol population. John, you want to address the second part of the question? John Pabrika Sure. So John, thank you for the question. So you know, currently our launch preparation are currently underway and that includes, you know, the analysis and evaluation of the marketplace and understanding currently the where the business segments are coming from, where likely future growth will come in from and also looking at where we will focus our activities and that would be including across three segments from a commercial perspective of payers in terms of who we'd want to target and what their formulary status is right now and all those associated timelines as well as, you know, preparations for Medicaid and Medicare areas and the activities we will pull start executing them upon the data of Our Phase three trials and part of the question that you asked in terms of understanding what those timelines are and so forth, we will be evaluating all of that as we put into our penetration segments for the market. Jonathan Miller Great, thanks so much. Jean Pierre Thank you. OPERATOR Our next question is from Maxwell Score with Morgan Stanley. Selena Hello, this is Selena on for Max. Thanks for taking our question. With your market research based on phase two results, what could you see in the phase three that you would expect to impact prescriber or payer response? Jean Pierre Aransa, I want to address a question. Arantha Oh sure, go ahead. Oh yes. So with your market research being primarily focused on like the phase two results, what could you see in the phase three results that you think might impact the prescriber repair response? So I think we see things along the same, you know, trends that we saw in phase two, which is great efficacy with low potential for drug, drug interaction of food effect, et cetera. So data consistent with phase two, which is what we see always in infectious diseases, the phase two data translates very well into phase three. I don't know if John wants to add something to this. John Pabrika No, I think I'm fine. Obviously we used the phase two data and that data was very well received. And the only thing I'll tell you is that the payers and other others are also very much interested in having a head to head trial because it's the first time and it was something that's very intriguing and important to them as well. And it plays into the previous question about being ready for launch readiness. And you know, one of those factors when you talk to the payers also is the head to head trial is very helpful to them. OPERATOR Thank you. Our next question comes from Andy Shea with William Blair. Andy Shea Thanks for taking our questions. First one has to do with the CB on. So looking at the modified intended tree population analysis plan, I think you basically calculated a SVR12 of 95% based on the phase 2 study. Looking across the landscape, I believe Gilead published some of the non compliant Ser 12 rates before and it's in the low 90s depending on the trials that you're looking at. So I'm curious about your thinking in terms of a superiority claim based on that delta. So just maybe commenting on the powering and sample size to see what level of confidence you have to achieve that milestone. Second question has to do with 587. You mentioned about the first in human study and the design I guess two parts. One is for this first in human study, what is the treatment duration that you intend to do and Then I guess in the real world setting, what do you expect the treatment duration to be? Thank you. Jean Pierre And it's a great question. First look, our goal is to have our regimen delivered to patients and prescriber and with the attributes that we have and we continue to demonstrate through clinical trials and nonclinical studies as well or clinical pharmacology studies as well. And so our goal is a non inferiority trial as you know, within 5% margin when we talk about the real world including the true intent to treat you right, it's around 90% webcluser. If we take the same value in our phase two we were about the same as the true intent to treat as you know. So look, let's see, you know, we don't want to speculate what it's going to be. We are going to actually evaluate, we think we have sufficient power definitely for the non inferiorities target and we'll see the superiority probably with the two trials because that we will increase even the power when we combine the trial and there is actually an analysis that it is planned and that has been shared with the FDA combining those two study and evaluated for potential superiority for the AT587. That's a good question first and then phase one is going to be the MAD is going to be a seven day as standard phase one as we did with other indications for the treatment duration we foresee that we will start the proof of concept which we believe we should be able to initiate by year end with a 12 weeks treatment duration. We have the chronic toxicology studies ongoing right now and we will have a peel out of three months sometimes in the fall. So definitely on time to open a CTA on the, on the proof of concept. We will start very likely based on the phase one data that we will generate. Probably as you have seen from the now from what we predicted, 600 milligram is a potential dose QD or BID. We'll see and that would be 12 weeks. Now we will upfront do continue this chronic toxicology studies up to six months in rat and nine months in monkey because potentially we'll see if we don't see high SVRA with 12 weeks we can potentially move to 24 weeks. Treatment duration is not an issue in this patient population as you know they take lifelong treatment against organ rejection. So compliance should be very good. And we have seen so far safety from a preclinical standpoint have been good and we can have quite the flexibility in the phase one as I have just indicated related to a QD or bid regimen, whether 12 weeks or 24 weeks. Andy Shea That's very helpful. Thank you. OPERATOR Thank you. We have reached the end of the question and answer session. I would like to turn the call back now to Jean Pierre Samodosi for closing remarks. Jean Pierre Thank you all for joining our first quarter 2026 earning conference call and thank you for your continued support. OPERATOR Thank you. This concludes today's conference. You may disconnect your lines at this time. Have a wonderful day. Disclaimer: This transcript is provided for informational purposes only. While we strive for accuracy, there may be errors or omissions in this automated transcription. For official company statements and financial information, please refer to the company's SEC filings and official press releases. Corporate participants' and analysts' statements reflect their views as of the date of this call and are subject to change without notice.