Company: RCUS
Filing Date: 2025-08-06
Form Type: 10-Q
Source: 0001724521-25-000101
Chunk: 278

Company: Arcus Biosciences, Inc.
Filing Date: 2025-08-06
Form: 10-Q
Item: Part I, Item 8
Chunk 278
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•Institutional Review Board ("IRB") refusing to approve, suspending or terminating the trial at an investigational site, precluding enrollment of additional subjects, or withdrawing their approval of the trial; 

•changes or amendments to the clinical trial protocol; 

•clinical sites deviating from the trial protocol or dropping out of a trial; 

•failure by our CROs to perform in accordance with good clinical practice ("GCP") requirements or applicable regulatory rules and guidelines in other countries;

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•manufacturing sufficient quantities of our investigational products, or obtaining sufficient quantities of combination therapies for use in clinical trials; 

•subjects failing to enroll or remain in our trials at the rate we expect, or failing to return for post-treatment follow-up, including subjects failing to remain in our trials;

•patients choosing an alternative product for the indications for which we are developing our investigational products or participating in competing clinical trials; 

•lack of adequate funding to continue a clinical trial or costs being greater than we anticipate; 

•subjects experiencing severe or serious unexpected drug-related adverse effects; 

•occurrence of serious adverse events in trials of the same class of agents conducted by other companies that could be considered similar to our investigational products; 

•selection of clinical endpoints that require prolonged periods of clinical observation or extended analysis of the resulting data; 

•or failure of our Contract Manufacturing Organization ("CMO") to produce clinical trial materials in sufficient quantities in accordance with current Good Manufacturing Practice ("cGMP"), regulations or other applicable requirements; and

•third parties being unwilling or unable to satisfy their contractual obligations to us in a timely manner.

We could also encounter delays if a clinical trial is suspended or terminated by us, by the IRBs of the institutions in which such trials are being conducted, by a Data Safety Monitoring Board for such trial or by the FDA or comparable foreign regulatory authorities. Such authorities may impose such a suspension or termination due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or applicable clinical trial protocols, adverse findings from inspections of clinical trial sites by the FDA or comparable foreign regulatory authorities, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using an investigational product, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial. In addition, changes in regulatory requirements and policies may occur, and we may need to amend clinical trial protocols to comply with these changes. Amendments may require us to resubmit our clinical trial protocols