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Sep 30, 2021
Arcus Biosciences Q3 2021 Earnings Report
Arcus Biosciences reported financial results for the third quarter ended September 30, 2021 and provided an update on the ARC-7 study of domvanalimab
Key Takeaways
Arcus Biosciences reported its Q3 2021 financial results, highlighting the initiation of Gilead's opt-in review process for their anti-TIGIT program and providing updates on their clinical studies, including ARC-7 and ARC-8. The company ended the quarter with $743.4 million in cash and investments, expecting it to fund operations through at least 2023.
Both domvanalimab-containing arms demonstrated differentiated clinical activity compared to that of zimberelimab alone in a second interim analysis of ARC-7, a Phase 2 study in first-line metastatic non-small cell lung cancer (NSCLC).
Gilead Sciences has initiated its opt-in review process for Arcus's anti-TIGIT program, with a decision expected before the end of 2021; if exercised, Arcus would receive a $275 million opt-in payment.
Updated data from ARC-8, a Phase 1 study of quemliclustat, Arcus's small molecule anti-CD73 inhibitor for pancreatic cancer, is planned for fall 2021.
Arcus ended the quarter with $743.4 million of cash and investments and funding through at least 2023.
Revenue by Segment
Forward Guidance
Arcus Biosciences anticipates several milestones in the near future across its clinical programs. Key expectations include full enrollment of ARC-7 by mid-2022 with data presentation later in the year, initiation of the PACIFIC-8 registrational Phase 3 study by the end of 2021, and an update on ARC-8 planned for this fall. The company is also planning additional Phase 3 studies of domvanalimab-based combinations and expects initial randomized data from ARC-4 in 1H22.
Positive Outlook
- ARC-7 is expected to be fully enrolled by mid-2022, and a data presentation, including progression-free survival data, is anticipated later in 2022.
- AstraZeneca and Arcus remain on track to initiate the PACIFIC-8 registrational Phase 3 study by the end of 2021.
- Several additional clinical studies of domvanalimab-based combinations are planned, including two additional Phase 3 studies anticipated to start in mid-2022.
- An update on ARC-8, Arcus's Phase I study of quemliclustat, is planned for this fall.
- Initial randomized data from ARC-4 is expected to be presented in 1H22.
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