Company: RCUS
Filing Date: 2025-10-06
Form Type: 8-K
Source: 0001724521-25-000107
Chunk: 2

Company: Arcus Biosciences, Inc.
Filing Date: 2025-10-06
Form: 8-K
Item: Item 8.01
Chunk 2
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0              0             3% (1)        6% (2)         3% (4)           

a Grade ≥3 TEAEs related to casdatifan that occurred in more than 5% of patients in the pooled analysis.

b Prespecified events of interest.

Expansion into Immunology and Inflammation (I& I)

The advanced discovery and preclinical programs disclosed by the Company in the presentation provide multiple opportunities to advance into the clinic in 2026. The Company expects the first clinical study from one or more of these programs to be initiated in 2026. Potential new drug candidates include:

•MRGPRX2 small-molecule inhibitor, a potential treatment for atopic dermatitis and chronic spontaneous urticaria

• TNF-a (TNFR1) small-molecule inhibitor, a potential treatment for rheumatoid arthritis (RA), psoriasis and inflammatory bowel disease (such as ulcerative colitis)

•CCR6 small-molecule inhibitor, a potential treatment for psoriasis

•CD89 monoclonal antibody, a potential treatment for RA

•CD40L small-molecule inhibitor, a potential treatment for multiple sclerosis and systemic lupus erythematosus

Cautionary Note Regarding Forward-Looking Statements

This report contains forward-looking statements. All statements regarding events or results to occur in the future contained herein are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements relating to the Company’s expectations regarding initiating one or more clinical studies from its immunology and inflammation programs and the unconfirmed objective response rate of ARC-20. All forward-looking statements involve known and unknown risks and uncertainties and other important factors that may cause the Company’s actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, risks associated with: interim data not being replicated in other studies evaluating casdatifan; risks associated with manufacturing or supplying product for clinical trials evaluating casdatifan; adverse data from toxicology studies that affect the Company’s ability to advance development candidates from its immunology and inflammation programs, uncertainties in timelines associated with the conduct of clinical studies and with respect to the regulatory approval process; changes in the competitive landscape for the Company’s programs; and the inherent uncertainty associated with pharmaceutical product development and clinical trials. Risks