Phase 3 C-BEYOND Trial Achieved Primary and Secondary Endpoints, Reinforcing Potential Best-in-Class Profile of BEM/RZR for Treatment of Hepatitis C Virus (HCV) Infection
Phase 3 C-FORWARD Trial for HCV on Track for Topline Results in Early 2027
Phase 1 Trial Evaluating AT-587 as Potential First-in-Class Treatment for Chronic Hepatitis E Virus (HEV) Infection Advances
Secured Non-dilutive Funding from Hercules Capital in an Amount Up to $200 Million
Company Holding Conference Call Today at 4:30 pm ET
BOSTON, Nov. 09, 2026 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (Atea or Company), a late-stage clinical biopharmaceutical company engaged in the discovery and development of oral antiviral therapeutics for serious viral diseases, today reported financial results for the third quarter ended September 30, 2026, and provided a business update.
During the third quarter, Atea announced positive topline results from C-BEYOND, the Company's Phase 3 trial in North America, with the regimen of bemnifosbuvir/ruzasvir (BEM/RZR) demonstrating statistical non-inferiority to Epclusa(R) (sofosbuvir/velpatasvir; SOF/VEL) in patients with hepatitis C virus (HCV), meeting the primary and secondary endpoints. Topline results from C-FORWARD, Atea's Phase 3 trial in patients with HCV outside of North America, are anticipated in early 2027. Results from C-FORWARD are expected to show the efficacy of BEM/RZR across a broad range of HCV genotypes, to support a New Drug Application (NDA) submission to the US Food and Drug Administration (FDA) targeted for mid-2027.
"The C-BEYOND results are strong and reinforce our conviction that the regimen of BEM/RZR will deliver a differentiated profile, including high HCV cure rates, short treatment duration, a low risk of drug-drug interactions and no food effect, which we believe are critical to drive broad adoption of BEM/RZR in clinical practice by prescribers," said Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of Atea Pharmaceuticals. "Healthcare systems are increasingly focusing on test-and-treat strategies as integral to enhanced HCV elimination efforts. BEM/RZR's profile is uniquely suited to meet the needs of patients and providers embracing this model."
"We anticipate the upcoming topline Phase 3 results of C-FORWARD should further validate the potential of BEM/RZR, if approved, to be a new pan-genotypic treatment option for prescribers to treat people living with HCV," Dr. Sommadossi added.
Chronic HCV infection remains an ongoing public health crisis. If left untreated, HCV can progress to cirrhosis, end-stage liver disease and liver cancer, and it remains one of the leading causes of liver cancer in the US, Europe and Japan. Approximately 47 million people worldwide are living with HCV, including up to four million people in the US, while new diagnoses continue to outpace annual cures. Additionally, many people living with HCV in the US are also managing other chronic conditions, and roughly 80% take multiple concomitant medications for common comorbidities such as heartburn, heart arrhythmia, gastroesophageal reflux disease (GERD) and opioid use disorder, which may increase the potential for drug-drug interactions with currently approved therapies.
"We are also rapidly advancing our HEV program and successfully completed the single ascending dose portion of our Phase 1 study for AT-587. We are now conducting the multiple ascending dose portion of this study and preparing for an anticipated proof-of-concept study in 2027," said Dr. Sommadossi. "There is a significant unmet need for HEV treatment among people who are immunocompromised and at high risk. We are building the foundation for what we currently anticipate may be a first-in-class direct-acting antiviral for chronic HEV and are excited about the potential of AT-587 to provide an important new treatment option for at-risk HEV patients."
HEV is a potentially serious liver disease that can lead to chronic infection, cirrhosis and liver failure in certain patient populations. At-risk populations include immunocompromised individuals, such as transplant recipients and patients taking immunosuppressants, among others.
Viral Hepatitis Pipeline Updates
Hepatitis C (HCV)
In July 2026, Atea announced positive topline results from C-BEYOND, its Phase 3 trial evaluating BEM/RZR for the treatment of chronic HCV infection. BEM/RZR demonstrated statistical non-inferiority compared to SOF/VEL in the modified intent-to-treat (mITT) population, achieving the trial's primary endpoint. In the mITT analysis (n=905, cirrhotic and non-cirrhotic), BEM/RZR achieved a 93.91% sustained virologic response (SVR) rate vs. 94.75% for SOF/VEL (Epclusa) at Week 24, encompassing SVR at 12 weeks post-treatment (accepted definition of cure for HCV) in both arms. Statistical non-inferiority was also met in secondary endpoints, including the per-protocol analysis. Rates of virologic failure across all populations were low and comparable between treatment arms. BEM/RZR was generally safe and well tolerated, with a safety profile comparable to SOF/VEL.
Atea continues to advance C-FORWARD, its Phase 3 trial being conducted outside North America. The trial is fully enrolled with more than 880 patients across 17 countries, with topline results expected in early 2027. C-FORWARD is expected to provide important efficacy data across a broad range of HCV genotypes, supporting a pan-genotypic profile.
In September 2026, multiscale modeling data from Atea's Phase 2 study of the 8-week BEM/RZR regimen in chronic HCV patients were published by the American Society for Clinical Pharmacology & Therapeutics. The analysis further elucidated the mechanism of action of BEM/RZR, modeling its effects on multiple stages of the viral lifecycle, including HCV replication, viral assembly and secretion.
Recently, Atea completed a Phase 1 study evaluating the co-administration of BEM/RZR with methadone or Suboxone(R) , two commonly used treatments for opioid use disorder. The co-administration was generally well tolerated in healthy volunteers and the study demonstrated a lack of drug-drug interaction. These data further support the potential use of BEM/RZR across the broad range of HCV patients encountered in real-world clinical practice.
Hepatitis E (HEV)
Atea continues to advance the Phase 1 clinical trial of AT-587, a potential first-in-class direct-acting antiviral for chronic HEV infection. The study has successfully completed the single ascending dose portion and is progressing through the multiple ascending dose portion part of the study, evaluating the safety, tolerability and pharmacokinetics of AT-587 in healthy volunteers. As Phase 1 development advances, Atea is also preparing for initiation of a proof-of-concept study anticipated in the first half of 2027. AT-587 is being developed to address chronic HEV in immunocompromised patients.
Corporate Update
On November 9, 2026, Atea announced that it entered into a credit facility agreement with Hercules Capital, Inc. for up to $200 million. The facility strengthens Atea's financial position and provides strategic and operational flexibility as the Company expands its commercial-related activities in anticipation of the launch of BEM/RZR in the US, if approved, for the treatment of HCV, and advances its clinical program for HEV. Under the agreement, Atea drew down $65 million at closing on November 6, 2026. Based on its current operating plan together with its current cash, cash equivalents and investments, the Company anticipates that these current resources will fund planned operations into mid-2028. Atea may, at its option and subject to the achievement of specified milestones and other terms and conditions of the loan agreement, access additional funding of up to $135 million. These additional borrowings could extend Atea's cash runway potentially to profitability assuming the successful commercial launch of BEM/RZR in the US and future expenditures consistent with the current operating plan.
Third Quarter 2026 Financial Results
Cash and Investments: $191.2 million at September 30, 2026 compared to $301.8 million at December 31, 2025.
Research and Development Expenses Research and development expenses decreased by $11.3 million from $38.3 million for the three months ended September 30, 2025 to $27.1 million for the three months ended September 30, 2026. The net decrease was primarily driven by a decrease in external spend for our HCV Phase 3 clinical development offset by an increase in external spend for HEV preclinical and clinical development activities. In addition, we had lower internal research and development expenses primarily related to lower stock-based compensation expense in the three months ended September 30, 2026.
General and Administrative Expenses: General and administrative expenses decreased by $0.3 million from $7.2 million for the three months ended September 30, 2025 to $6.9 million for the three months ended September 30, 2026. The net decrease was primarily related to lower stock-based compensation expense.
Interest Income and Other, Net: Interest income and other, net, decreased by $1.8 million for the three months ended September 30, 2026 compared to the three months ended September 30, 2025, primarily due to lower investment balances.
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