Phase 3 C-BEYOND Trial Met Primary and Secondary Endpoints, with a Short 8-week Duration for Patients Without Cirrhosis Supporting a Potential Best-in-Class Profile of BEM/RZR for Treatment of HCV
C-FORWARD Phase 3 Trial Outside North America on Track with Topline Results Expected Early Q1 2027
AT-587 Phase 1 Clinical Trial Advancing for Treatment of Hepatitis E Virus (HEV)
Company Holding Conference Call Today at 4:30 pm ET
BOSTON, Aug. 12, 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 second quarter ended June 30, 2026, and provided a business update.
In July, Atea announced positive topline results from C-BEYOND, its Phase 3 trial conducted in North America evaluating the regimen of bemnifosbuvir and ruzasvir (BEM/RZR) for the treatment of chronic hepatitis C virus (HCV) infection compared to the regimen of sofosbuvir and velpatasvir (SOF/VEL; Epclusa) in the modified intent-to-treat (mITT) population, achieving the trial's primary endpoint. C-BEYOND enrolled patients reflective of the current real-world population living with HCV in the US and Canada. Patients in C-BEYOND included those who are taking concomitant medications (89%), reported injection drug use as the HCV route of transmission (>= 55%), diagnosed with a comorbid psychiatric disorder (66%), prematurely discontinued treatment, lost to follow-up or did not adhere to protocol treatment (>10%), underscoring the importance of a simplified treatment option with a short 8-week duration for most patients, low risk of drug-drug interactions, and convenience with no food effect.
"The positive Phase 3 C-BEYOND results announced last month represent a pivotal milestone for Atea, validating BEM/RZR's potential to become a highly differentiated, best-in-class treatment for hepatitis C virus (HCV)," said Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of Atea Pharmaceuticals. "In the US, a significant HCV treatment gap remains, currently only about 50%, or 85,000 people diagnosed are being treated annually, contributing to the increasing population of up to four million people who are already chronically infected. BEM/RZR's differentiated profile with a short eight-week regimen for non-cirrhotic patients, a low risk of drug-drug interactions and no food restrictions, has the potential to streamline prescribing decisions, and help expand treatment to more patients."
"Looking ahead, we remain focused on delivering topline results from our second Phase 3 trial, C-FORWARD, in early first quarter 2027 while continuing to advance AT-587 for the treatment of HEV, where a substantial commercial opportunity remains due to the lack of any approved therapies," Dr. Sommadossi added.
Viral Hepatitis Pipeline Updates
Hepatitis C (HCV)
C-BEYOND topline Phase 3 results include:
-- In the modified intent to treat (mITT) primary endpoint analysis (n=905,
cirrhotic and non-cirrhotic), BEM/RZR achieved a 93.9% sustained
virologic response (SVR) rate vs. 94.8% for SOF/VEL (marketed in the US
under the brand] Epclusa(R)) at Week 24, encompassing SVR at 12 weeks
(accepted definition of cure for HCV) in both arms.
-- The trial achieved its primary endpoint of statistical non-inferiority,
with a 95% confidence interval for difference in SVR rates within the
prespecified 5% margin. Statistical non-inferiority was also met in
secondary endpoints, including the per-protocol analysis.
-- The mITT analysis in patients without cirrhosis (n=721) showed BEM/RZR (8
weeks of treatment) achieved a 93.5% SVR rate vs. 94.6% for SOF/VEL (12
weeks of treatment). In patients with cirrhosis (12 weeks treatment in
both arms) (n=184), BEM/RZR achieved a 95.4% SVR rate vs. 95.4% for
SOF/VEL.
-- Rates of virologic failure across all populations were low and comparable
between treatment arms.
-- BEM/RZR was generally safe and well tolerated with no drug-related
serious adverse events or drug related early treatment discontinuations,
and safety was comparable between treatment arms.
Today, the US Centers for Disease Control $(CDC)$ reports approximately 160,000 new HCV infections annually with only an estimated 85,000 patients(1) receiving treatment with the current standard of care therapies leaving approximately 75,000 untreated annually, enabling a potential $2.5 billion annual net sales US market opportunity. In the US alone, up to 4 million people are estimated to be infected with HCV. The C-BEYOND results reinforce BEM/RZR's potential to address this growing treatment gap in today's patient population and contribute to advancing the World Health Organization's HCV elimination goal.
Atea is advancing C-FORWARD, its second Phase 3 trial, being conducted outside North America. Patient enrollment for C-FORWARD was completed in June 2026 with more than 880 patients across 17 countries. Topline results are expected in early Q1 2027 and will provide additional efficacy data across a broader range of HCV genotypes more commonly found outside of the US and Canada.
Following the recent topline readout for C-BEYOND and pending results from C-FORWARD, Atea anticipates submitting a new drug application (NDA) to the US Food & Drug Administration (FDA) in the second quarter of 2027.
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(1) IQVIA: NRx (NPA) Audit for the period Jan 2025 -- Dec 2025 reflecting estimates of real-world activity.
Hepatitis E (HEV)
In July, Atea initiated a first-in-human Phase 1 clinical trial evaluating, AT-587, for the treatment of chronic HEV. Atea's focus will be in an immunocompromised patient population infected with HEV genotypes 3 or 4. There is currently no approved antiviral therapy for HEV and current off-label treatments, including ribavirin, have limited efficacy and tolerability, underscoring a clear and urgent unmet medical need.
Second Quarter 2026 Financial Results
Cash and Investments: $219.5 million at June 30, 2026 compared to $301.8 million at December 31, 2025.
Research and Development Expenses: Research and development expenses decreased by $4.1 million from $32.3 million for the three months ended June 30, 2025 to $28.2 million for the three months ended June 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 development and clinical development startup activities. The decrease in HCV Phase 3 clinical development external spend was principally the result of the completion of the Week 24 post treatment visits by patients in our C-BEYOND Phase 3 clinical trial. The decrease in internal research and development expenses was primarily related to lower stock-based compensation expense in the three months ended June 30, 2026.
General and Administrative Expenses: General and administrative expenses decreased by $2.1 million from $9.1 million for the three months ended June 30, 2025 to $7.0 million for the three months ended June 30, 2026. The net decrease was primarily related to lower stock-based compensation expense and lower professional fees.
Interest Income and Other, Net: Interest income and other, net, decreased by $2.2 million for the three months ended June 30, 2026 compared to the three months ended June 30, 2025, primarily due to lower investment balances.
Income Taxes: Income tax expense was $0.1 and $0.2 million for the three months ended June 30, 2026 and 2025, respectively.
Condensed Consolidated Statement of Operations and
Comprehensive Loss
(in thousands, except share and per share amounts)
(unaudited)
Three Months Ended Six Months Ended
June 30, June 30,
2026 2025 2026 2025
----------- ----------- -----------
Operating expenses
Research and
development $ 28,150 $ 32,275 $ 69,284 $ 61,859
General and
administrative 6,949 9,070 13,823 18,527
Total operating
expenses 35,099 41,345 83,107 80,386
---------- ---------- ---------- ----------
Loss from operations (35,099) (41,345) (83,107) (80,386)
Interest income and
other, net 2,190 4,391 4,808 9,363
Loss before income
taxes (32,909) (36,954) (78,299) (71,023)
Income tax expense (24) (207) (74) (410)
Net loss $ (32,933) $ (37,161) $ (78,373) $ (71,433)
---------- ---------- ---------- ----------
Other comprehensive
loss
Unrealized income
(loss) on
available-for-sale
investments 1 (81) (270) (196)
Comprehensive loss $ (32,932) $ (37,242) $ (78,643) $ (71,629)
========== ========== ========== ==========
Net loss per share -
basic and diluted $ (0.41) $ (0.44) $ (0.99) $ (0.85)
========== ========== ========== ==========
Weighted-average
number of common
shares - basic and
diluted 80,050,518 83,747,335 79,183,301 84,449,318
========== ========== ========== ==========
Selected Condensed Consolidated Balance Sheet Data
(in thousands)
(unaudited)
June 30, 2026 December 31, 2025
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