Atea Pharmaceuticals Reports First Quarter 2025 Financial Results and Provides Business Update

Enrollment Ongoing in Phase 3 C-BEYOND Trial for Treatment of HCV

Full Phase 2 Results for Regimen of Bemnifosbuvir and Ruzasvir for HCV and Results from Three Additional Phase 1 Studies Supporting Potential Best-in-Class Profile Presented at European Association for the Study of the Liver (EASL) Congress 2025

Virtual Investor Event with Key Opinion Leader Insights on HCV to be Held May 14, 2025, at 10:00 AM ET

BOSTON, May 12, 2025 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (Atea or Company), a clinical-stage biopharmaceutical company engaged in the discovery and development of oral antiviral therapeutics for serious viral diseases, today reported financial results for the first quarter ended March 31, 2025 and provided a business update.

The Company's combination regimen of bemnifosbuvir $(BEM.UK)$, a nucleotide analog polymerase inhibitor, and ruzasvir (RZR), an NS5A inhibitor, is in Phase 3 development for the treatment of hepatitis C virus (HCV).

"Atea has made very significant progress thus far in 2025, initiating and continuing to enroll patients in C-BEYOND, our Phase 3 clinical trial evaluating the regimen of bemnifosbuvir and ruzasvir for the treatment of HCV in the US and Canada," said Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of Atea. "We are also focused on initiating our second Phase 3 trial, C-FORWARD, which will be conducted at clinical sites outside of North America. We expect enrollment of patients in C-FORWARD to begin mid-year."

"We are very encouraged by the positive results of the Phase 2 clinical study and additional data presented at EASL 2025 supporting the efficacy, safety and potential best-in-class profile of our regimen of bemnifosbuvir and ruzasvir, including short treatment duration, low risk for drug-drug interactions, and convenience with no food effect," continued Dr. Sommadossi. "We believe our regimen, if approved, has the potential to increase the number of treated and cured HCV patients and to disrupt the global HCV market of approximately $3 billion in net sales."

HCV KOL Investor Event to be Held May 14, 2025 at 10:00 AM ET

Atea will host a virtual key opinion leader $(KOL)$ investor event with a panel of HCV experts and prescribers on Wednesday, May 14, 2025, at 10:00 AM ET. To register, click here.

This KOL event will replace Atea's first quarter 2025 earnings conference call, and Quarterly calls will resume with the second quarter 2025 financial results.

This investor event will include an expert panel of several leaders in hepatology, gastroenterology, infectious diseases, and HCV treatments in the US, Canada and Europe. These experts and prescribers will discuss the current challenges experienced by people living with HCV, the full results of Atea's global Phase 2 study evaluating the regimen of BEM/RZR for the treatment of HCV, and what a new optimized HCV therapy could provide for prescribers and patients. Company management will discuss the HCV commercial market opportunity and the ongoing global Phase 3 clinical development.

Summary of Results Presented at EASL

Poster Title: Efficacy and Safety of Bemnifosbuvir and Ruzasvir after 8 Weeks of Treatment in Patients with Chronic Hepatitis C Virus (HCV) Infection (TOP-251)

Conclusion: The Phase 2 study results demonstrated that an 8-week combination regimen of BEM (550 mg) and RZR (180 mg) achieved SVR12 in 98% of treatment-adherent patients and 95% of patients regardless of treatment adherence. The regimen was safe and well-tolerated with low rates of virologic failure and no study-drug-related serious adverse events or treatment discontinuations. Treatment emergent adverse events (TEAEs) were reported in 43% (118/275) of patients. Most TEAEs were mild to moderate in intensity, with headache (9%) and nausea (8%) being the most reported. These results reinforce the potential of the combination regimen of BEM and RZR as a best-in-class treatment for HCV.

Poster Title: Pharmacokinetics of Bemnifosbuvir in Participants with Hepatic Impairment (WED-278)

Conclusion: A Phase 1 pharmacokinetic study evaluating a single 550 mg dose of BEM in participants with varying degrees of hepatic impairment showed increased drug exposure in individuals with moderate to severe liver dysfunction. However, these changes did not meaningfully affect levels of AT-273, the plasma marker for the active intracellular antiviral metabolite of BEM. No safety concerns were identified. These results support the use of BEM without dose adjustment in patients with hepatic impairment.

Poster Title: No DDI Between Bemnifosbuvir/Ruzasvir and Bictegravir/Emtricitabine/Tenofovir Alafenamide (WED-279)

Conclusion: Findings from a Phase 1 drug-drug interaction study in healthy participants demonstrated that co-administration of BEM/RZR with the standard human immunodeficiency virus (HIV) regimen bictegravir/emtricitabine/tenofovir alafenamide (B/FTC/TAF) resulted in no clinically significant pharmacokinetic changes. The co-administered HCV/HIV combinations were generally safe and well tolerated. These results support the future inclusion of HCV/HIV co-infected patients receiving these HIV therapies in the Phase 3 clinical development program for BEM/RZR.

It is estimated that in the US as many as 6 to 30% of HCV patients are co-infected with HIV.(1)

Poster Title: Pharmacokinetics of Bemnifosbuvir in Participants with Renal Impairment (WED-280)

Conclusion: A Phase 1 renal impairment study showed that a single 550 mg dose of BEM was safe and well-tolerated across participants with normal kidney function, moderate-to-severe renal impairment, and those with end-stage renal disease on hemodialysis. While the circulating inactive nucleoside metabolites of BEM increased as expected in renally impaired individuals, exposure of BEM remained consistent. These findings suggest that BEM may be used without dose adjustment in patients with renal dysfunction, including those undergoing dialysis.

About the Bemnifosbuvir / Ruzasvir HCV Phase 3 Program

Atea's HCV Phase 3 program includes two open-label Phase 3 trials, C-BEYOND in the US and Canada, and C-FORWARD, a global trial outside of North America. Each Phase 3 trial will enroll approximately 880 treatment-naïve patients, including those with and without compensated cirrhosis. The trials will compare the fixed-dose combination (FDC) regimen of BEM/RZR to the FDC regimen of sofosbuvir and velpatasvir. The regimen of BEM/RZR will be administered orally once-daily for eight weeks (in patients without cirrhosis) or 12 weeks (in patients with compensated cirrhosis) while the regimen of sofosbuvir and velpatasvir will be administered orally once-daily for 12 weeks to all patients, with or without compensated cirrhosis.

The primary endpoint for each trial is HCV RNA < lower limit of quantitation (LLOQ) at 24 weeks from the start of treatment and encompasses sustained virologic response 12 weeks post-treatment (SVR12) in each arm. Measurement at 24 weeks from the start of treatment is to ensure the primary endpoint occurs at the same relative timepoint from the start of treatment in all patients. Patient enrollment in the C-BEYOND trial is ongoing and enrollment in the C-FORWARD trial is expected to begin in mid-2025.

The initiation of the Phase 3 program follows a successful engagement with the US Food and Drug Administration (FDA) at an End-of-Phase 2 meeting in January 2025, shortly after the Company announced the topline results from the Phase 2 study evaluating the potential best-in-class regimen of BEM/RZR, including data demonstrating that the regimen met its primary endpoints of efficacy (SVR12) and safety.

Business and Organizational Updates

   -- In December 2024, Atea engaged Evercore, a global independent investment 
      bank, to identify potential opportunities to enhance shareholder value. 
      The process includes a review of a broad range of strategic alternatives, 
      including strategic partnerships, acquisition, merger, or other business 
      combination, sale of assets or other strategic transactions. The process 
      is ongoing, and the Company continues to evaluate all options to maximize 
      shareholder value. 
   -- In the first quarter 2025, to enhance efficiency in the management of 
      infrastructure expenditures, Atea reduced its workforce by approximately 
      25%. This workforce reduction is expected to result in cost savings of 
      approximately $15 million through 2027. 
   -- In February 2025, Arthur S. Kirsch was appointed to the Company's Board 
      of Directors. Mr. Kirsch has extensive knowledge of the healthcare and 
      life sciences industries gained from decades of investment banking and 
      capital markets experience as well as extensive public board and 
      strategic experience. 
   -- In April 2025, Atea further refreshed its Board of Directors with the 
      appointment of Howard H. Berman, PhD. The appointment of Dr. Berman, who 
      is currently serving as an observer, will become effective upon the 
      completion of Atea's 2025 Annual Meeting of Stockholders. Dr. Berman has 
      over 20 years of entrepreneurial and life science industry experience 
      working at the interplay of science and business. 
 
   -- In April 2025, Atea announced that its Board had authorized the 
      repurchase of up to $25 million of the Company's common stock. This 
      authorization reflects the Company's commitment to return capital to 
      shareholders, while maintaining the capacity to complete its global Phase 
      3 HCV program and position Atea for long-term success. 

First Quarter 2025 Financial Results

Cash, Cash Equivalents and Marketable Securities: $425.4 million at March 31, 2025, compared to $454.7 million at December 31, 2024.

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