Atea Pharmaceuticals Q2 2024 Financial Results and Business Update

Atea Pharmaceuticals, Inc., a biopharmaceutical company focused on developing oral antiviral treatments for serious viral diseases, has shared significant updates on its progress for the second quarter ending June 30, 2024. According to CEO and founder Jean-Pierre Sommadossi, the year has been marked by notable advancements and operational success. Specifically, the company completed patient enrollment for both its global Phase 3 SUNRISE-3 study targeting COVID-19 and a global Phase 2 study on a treatment for hepatitis C virus (HCV).

The SUNRISE-3 trial is a global, multicenter, randomized, double-blind, placebo-controlled Phase 3 study. It focuses on high-risk outpatients with mild to moderate COVID-19, comparing bemnifosbuvir against a placebo. Patients received either the drug or a placebo twice daily for five days, alongside the standard of care. Results for the primary endpoint, which is all-cause hospitalization or death by Day 29, are anticipated in the latter half of 2024. Secondary endpoints will measure patient outcomes up to Day 60 post-treatment. Notably, the majority of the study’s 2,295 participants were enrolled in the US, indicating a significant unmet need for new oral COVID-19 treatments.

The trial includes two key populations based on the standard of care (SOC) used: a supportive care group (primary analysis) and a combination antiviral group (secondary analysis) aimed at evaluating bemnifosbuvir both as a standalone treatment and in combination with other antiviral drugs. The high-risk patient population mostly includes older adults and those with specific risk factors such as immunocompromised conditions, irrespective of their vaccination status.

Additionally, Atea has been working on developing second-generation protease inhibitors for COVID-19 as part of its multi-faceted approach against the virus. The identification of a novel compound with a distinct profile is in progress.

In the realm of HCV, Atea completed enrollment for its global Phase 2 study in June 2024. This study investigates bemnifosbuvir (an NS5B polymerase inhibitor) and ruzasvir (an NS5A inhibitor) in treatment-naïve HCV-infected patients, including those with compensated cirrhosis. The study aims to assess the safety and efficacy of an eight-week treatment regimen. Results for the primary endpoint, sustained virologic response at Week 12 post-treatment (SVR12), are expected in the fourth quarter of 2024. Preliminary data from the EASL Congress showed promising results, with a high SVR12 rate and a favorable safety profile.

Atea has also chosen a fixed-dose combination tablet for its Phase 3 HCV program, which reduces the daily pill count from four to two, thus increasing patient convenience. This formulation showed no significant food effect on drug exposure in recent studies.

Financially, Atea reported cash, cash equivalents, and marketable securities totaling $502.2 million as of June 30, 2024, a decrease from $578.1 million at the end of 2023. Research and development expenses rose to $34.7 million for the quarter, primarily driven by progress in the Phase 3 COVID-19 and Phase 2 HCV studies. General and administrative expenses decreased slightly to $12.2 million, mainly due to lower professional fees. Interest income and other net figures also saw a decrease due to lower investment balances. The company reported a net loss of $40.5 million for the second quarter of 2024 compared to $28.2 million for the same period in 2023.

In summary, Atea Pharmaceuticals has made significant strides in its clinical programs for COVID-19 and HCV, with critical data expected later in the year. The company remains financially robust and focused on its mission to provide effective treatments for serious viral infections.

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