Atea Pharmaceuticals Q3 2024 Financial Results and Business Update

Atea Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company committed to developing oral antiviral treatments for severe viral infections, has disclosed its financial outcomes for the third quarter ending September 30, 2024, alongside a key business update. The company has underlined its ongoing advancements in the Hepatitis C Virus (HCV) program, especially with the combination of bemnifosbuvir and ruzasvir, presenting a highly promising profile.

CEO Jean-Pierre Sommadossi, PhD, emphasized the company’s substantial headway with the bemnifosbuvir and ruzasvir combination. Atea is preparing to reveal preliminary results from its Phase 2 study in early December and is set to initiate the global Phase 3 program in early 2025. The persistent high rate of new HCV infections necessitates innovative therapies, particularly for patients with substance abuse issues and other health complications. The HCV market is projected to remain substantial, with global sales exceeding $3 billion, and the U.S. market contributing significantly to this figure. Atea aims to capture notable market share with their combination therapy, which offers convenience and a short treatment duration with minimal drug interactions, potentially increasing the number of patients cured.

In its global Phase 2 clinical study, Atea is assessing the safety and efficacy of a combination of bemnifosbuvir, a nucleotide analog polymerase inhibitor, and ruzasvir, an NS5A inhibitor, in 275 treatment-naïve patients with and without compensated cirrhosis. This study involves an eight-week treatment regimen with primary endpoints focused on safety and sustained virologic response (SVR12) 12 weeks post-treatment. Secondary endpoints include evaluating SVR12 irrespective of treatment adherence, virologic failure, and resistance. Preliminary results are expected in early December 2024.

At the European Association of the Study of the Liver (EASL) Congress in June 2024, Atea shared data from the initial cohort of the Phase 2 study, revealing a 97% SVR12 rate among efficacy-evaluable patients over an eight-week treatment period. Two subjects experienced relapse, attributed to non-adherence rather than viral resistance. Notably, the combination achieved a 100% SVR12 rate in patients with the challenging-to-treat genotype 3 of HCV. The combination therapy was well-tolerated, with no serious adverse events or treatment discontinuations.

Further preclinical data presented at EASL showed a high resistance barrier and favorable pharmacokinetics (PK) for bemnifosbuvir, along with a low risk of drug-drug interactions for ruzasvir. Atea is planning an End of Phase 2 meeting with the U.S. FDA in early 2025 to support the initiation of the Phase 3 program. The company is also developing a fixed-dose combination (FDC) tablet to reduce the daily pill count from four to two, enhancing patient convenience without food effect concerns.

Atea will present three posters at The Liver Meeting 2024 in mid-November, offering additional safety and resistance data for bemnifosbuvir and modeling data on the combination’s effectiveness in blocking HCV replication and viral processes. The American College of Pharmacometrics meeting will feature data from an integrated population PK model of bemnifosbuvir and its metabolites.

In other developments, Atea announced results from the Phase 3 SUNRISE-3 trial in September 2024, evaluating bemnifosbuvir for mild to moderate COVID-19. The trial, involving over 2,200 high-risk patients, did not meet its primary endpoint of reducing hospitalization or death. Atea has decided not to pursue regulatory approval for bemnifosbuvir for COVID-19, given the trial outcomes and changing pandemic landscape.

Financially, Atea reported cash, cash equivalents, and marketable securities totaling $482.8 million as of September 30, 2024. Research and development expenses decreased by $2.0 million year-over-year, primarily due to reduced spending on the COVID-19 trial but offset by higher costs for the HCV trial. General and administrative expenses also decreased by $1.6 million, mainly due to lower professional fees. Interest income and other net decreased by $1.6 million, reflecting lower investment balances.

Atea’s focus remains on advancing its HCV program, leveraging its expertise in antiviral drug development to meet the significant unmet needs of patients with serious viral infections. The company continues to develop oral therapies, particularly the combination of bemnifosbuvir and ruzasvir, aiming for substantial market impact and improved patient outcomes.