Company: RCUS
Filing Date: 2025-05-06
Form Type: 10-Q
Source: 0001724521-25-000063
Chunk: 325

Company: Arcus Biosciences, Inc.
Filing Date: 2025-05-06
Form: 10-Q
Item: Part I, Item 2
Chunk 325
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 whom it is not contraindicated.

Etrumadenant - we are not pursuing a Phase 3 study at this time 

Significant Developments

The following is a summary of the recent significant developments affecting our business:

Corporate Developments

•In February 2025, we announced that we retain full global development and commercial rights, subject to Taiho’s option right for the Taiho Territory after Gilead's time-limited exclusive option rights to our HIF-2α program (including casdatifan) expired.

•In February 2025, we issued through an underwritten offering, 13.6 million shares of our common stock at a price of $11.00 per share, for total gross proceeds of approximately $150 million, before deducting underwriting discounts, commissions and offering expenses. 

22

HIF-2⍺ Program

•In February 2025, we presented clinical data from three monotherapy expansion cohorts of ARC-20 in a rapid oral session at the 2025 American Society of Clinical Oncology ("ASCO") Genitourinary Symposium. At the time of data cut-off (January 3, 2025), observations from the expansion cohorts included: 

◦A 9.7-month median progression-free survival ("mPFS") was reached for the 50mg twice-a-day (BID) casdatifan monotherapy cohort; mPFS was not yet reached for other cohorts. 

◦Confirmed objective response rate ("ORR") ranged from 25% to 33%, with two of the cohorts exceeding 30% (including one partial response that confirmed after the data cut-off). 

◦Rates of primary progressive disease (progression at or before their first disease assessment) ranged from 14% to 19%. 

Most patients (81-87%) experienced disease control with either a partial response or stable disease and were still on treatment. 

Etrumadenant

•In March 2025, we engaged with the U.S. Food and Drug Administration ("FDA") regarding promising results from the ARC-9 study evaluating etrumadenant in third-line metastatic colorectal cancer ("mCRC"); although the FDA’s feedback confirmed the potential for a registrational path for this program in third-line mCRC, based on our strategic priorities, we are not pursuing a Phase 3 study at this time.

Components of Operating Results 

Revenues

We have not generated any revenue from product sales and do not expect