Atea Pharmaceuticals Q1 Earnings Call Highlights

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.

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.

Phase 3 HCV Readouts Expected in 2026

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.

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.

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.

Company Highlights Potential Differentiation

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.

Commercial Strategy Focuses on HCV Treatment Access

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.

HEV Program Moves Toward First-in-Human Study

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.

Spending Remains Focused on HCV Program

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.

About Atea Pharmaceuticals (NASDAQ:AVIR)

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.