Company: RCUS
Filing Date: 2025-05-06
Form Type: 10-Q
Source: 0001724521-25-000063
Chunk: 341

Company: Arcus Biosciences, Inc.
Filing Date: 2025-05-06
Form: 10-Q
Item: Part I, Item 2
Chunk 341
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 a trial or reaching a consensus with regulatory authorities on trial design; 

•the FDA or comparable foreign regulatory authorities disagreeing as to the implementation of our clinical trials; 

•any failure or delay in reaching an agreement with Contract Research Organizations (“CROs”) and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; 

•delays in identifying, recruiting and training suitable clinical investigators;

•obtaining approval from one or more institutional review boards, or ethics committees at clinical trial sites; 

•IRBs 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 GCP requirements or applicable regulatory rules and guidelines in other countries;

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

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•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 CMOs 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