Arcus Biosciences Q1 2024 Financial Results and Pipeline Update

Arcus Biosciences, Inc., a clinical-stage biopharmaceutical company, has reported its financial results for the first quarter ending March 31, 2024, and provided updates on its clinical-stage investigational molecules. Arcus is focused on developing differentiated molecules and combination therapies for cancer patients, targeting multiple cancer types including lung, gastrointestinal, and kidney cancers.

CEO Terry Rosen highlighted the company's progress, noting several upcoming presentations at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. These include updated data from the EDGE-Gastric trial evaluating domvanalimab plus zimberelimab and chemotherapy in upper GI cancers, and data from ARC-9 evaluating an etrumadenant plus zimberelimab-based treatment combination in third-line metastatic colorectal cancer.

Arcus is also anticipating the presentation of data from the casdatifan 100 mg expansion cohort of ARC-20, a Phase 1/1b study of casdatifan in clear cell renal cell carcinoma (ccRCC), during the second half of 2024. Additionally, enrollment for the Phase 3 STAR-221 (upper GI cancers) and STAR-121 (non-small cell lung cancer) studies is expected to complete by mid-year and the second half of 2024, respectively.

Financially, Arcus is well-positioned with $1.1 billion in cash, cash equivalents, and marketable securities, providing a runway into 2027. The company reported $145 million in revenues for the first quarter of 2024, a significant increase from $25 million in the same period in 2023. This increase was primarily driven by a $107 million cumulative catch-up to revenue relating to the Gilead collaboration amendments.

Research and development expenses rose to $109 million in the first quarter of 2024 from $81 million in the same period in 2023. The increase was mainly due to higher clinical manufacturing, clinical trial, and headcount-related costs. General and administrative expenses were $32 million, slightly up from $30 million in the first quarter of 2023.

Arcus also incurred a $20 million non-cash impairment charge related to its office space lease agreements in the first quarter of 2024. Despite these expenses, the company reported a net loss of $4 million for the first quarter of 2024, compared to a net loss of $80 million in the same period in 2023.

Arcus's comprehensive pipeline includes multiple programs targeting TIGIT, the adenosine axis (CD73 and A2a/A2b receptors), HIF-2a, AXL, and PD-1, across various cancer types. The company is advancing several late-stage clinical trials, including:

- Domvanalimab plus Zimberelimab: Results from the Phase 2 EDGE-Gastric trial and the completion of enrollment for the Phase 3 STAR-221 and STAR-121 studies in GI cancers and NSCLC, respectively.

- Casdatifan: Multiple expansion cohorts in ccRCC, with several data presentations expected over the next 18 months and the initiation of a Phase 3 study in combination with a TKI in ccRCC anticipated in the first half of 2025.

- CD73-Adenosine Axis: Data from the ARC-9 and MORPHEUS-PDAC studies are further validating the efficacy of quemliclustat and etrumadenant in various cancer settings.

Arcus is continuing dose escalation for AB801, a small-molecule AXL inhibitor, and plans to advance this molecule into expansion cohorts in NSCLC by early 2025. The company’s robust financial position and strategic collaboration with Gilead are expected to support its ongoing and future clinical development programs.

Overall, Arcus Biosciences is making significant strides in advancing its pipeline of investigational cancer therapies, with several key milestones anticipated in the coming months and years. The company remains focused on delivering potentially first- and best-in-class treatments to cancer patients with high unmet needs.

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