Company: RCUS
Filing Date: 2025-10-28
Form Type: 10-Q
Source: 0001724521-25-000116
Chunk: 358

Company: Arcus Biosciences, Inc.
Filing Date: 2025-10-28
Form: 10-Q
Item: Part I, Item 2
Chunk 358
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 and planned clinical trials for our investigational products could significantly affect our product development timelines and product development costs and harm our financial position. 

We do not know whether our planned clinical trials will begin on time or be completed on schedule, if at all. The timing for commencement, data readouts and completion of clinical trials can be delayed for a number of reasons, including delays related to: 

•inability to generate sufficient preclinical, toxicology, or other in vivo or in vitro data to support the initiation or continuation of clinical trials;

•obtaining allowance or approval from regulatory authorities to commence 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 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; 

•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