Arcus Biosciences, Inc.
For the period ended Sep 30, 2026. Filed Nov 4, 2026.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2026 · Filed Nov 4, 2026
RCUS$18.28+3.3%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-06-30; filed 2026-08-05.
0001724521-26-000044
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-11-04.
0001724521-26-000058
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 86 previous paragraphs and 95 current paragraphs.
61 unchanged; 22 reworded; 11 added; 2 removed; 1 previous and 1 current paragraphs rearranged.
Tables are not compared: 4 previous and 4 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (11)
Current report
•In October 2026, we issued through an underwritten public offering, 16.4 million shares of our common stock at a public offering price of $17.50 per share, for total gross proceeds of approximately $288 million, before deducting underwriting discounts, commissions and offering expenses.
Current report
•In October 2026, we announced new data from the ARC-20 platform study evaluating casdatifan, alone or in combination, as a first-, second- and late-line treatment for clear cell renal cell carcinoma ("ccRCC"). This included the following data as of the data cutoff date (September 4, 2026):
Current report
▪First-line TKI-free combinations
Current report
◦Casdatifan plus zimberelimab (anti-PD-1) (n=30): with 11.5 months of median follow up, landmark progression-free survival ("PFS") was 86% and 69% at six and 12 months, respectively, the confirmed objective response rate ("cORR") was 50%, and the rate of primary progression (progression at or before the first scan) was 6.7%. No unexpected safety signals were observed at the time of data cutoff. The regimen showed safety data that are consistent with those observed in other cohorts or prior studies of each molecule.
Current report
◦Casdatifan plus ipilimumab (anti-CTLA-4) plus zimberelimab: with three months of median follow up, only one patient out of 24 patients (4%) who had reached a first scan experienced primary progression. There were no unexpected safety signals observed in the 31 patients enrolled that received at least one dose of casdatifan plus ipilimumab and zimberelimab at the time of data cutoff. Grade 3 and higher immune-mediated adverse events were generally consistent with those associated with ipilimumab and nivolumab in frequency, severity and timing.
Current report
•Second-line combination
Current report
◦Casdatifan plus tyrosine kinase inhibitor ("TKI") cabozantinib: with 21.3 months of median follow up (n=43), median PFS was 14.5 months, 18-month landmark overall survival was 77%, cORR was 44% and primary progression was 5%. Casdatifan plus cabozantinib demonstrated similar efficacy, whether or not patients previously received TKI therapy. TKI-pretreated patients represent approximately 60% of 2L patients in current practice and derive diminished benefit from subsequent TKI therapies. No unexpected safety signals were observed at the time of data cutoff (n=44). The regimen showed safety data that are consistent with those observed in other cohorts or prior studies of each molecule.
Current report
•Late-line monotherapy
Current report
◦Casdatifan monotherapy (n=121): with 28 months of median follow up in the four pooled monotherapy cohorts, median overall survival was 35 months, median PFS was 13 months and cORR was 36%. PFS data were similar whether patients had received one, two or three prior TKI-inclusive treatments. No unexpected safety signals were observed, and casdatifan showed acceptable and manageable adverse events across all doses.
Current report
** Includes PACIFIC-8, STAR-121, STAR-221, and ARC-10. These studies have been discontinued, completed or substantially completed.
Current report
In October 2026, we issued through an underwritten offering, 16.4 million shares of our common stock at a price of 17.50 per share, for total gross proceeds of approximately $288 million, before deducting underwriting discounts, commissions and offering expenses.
Removed paragraphs (2)
Previous report
•In June 2026, we announced a clinical trial collaboration and supply agreement with Bristol Myers Squibb ("BMS"). Under the agreement, we will supply casdatifan, our investigational small-molecule HIF-2α inhibitor, to be evaluated as part of the BMS-sponsored Phase 1/2 ROSETTA RCC-208 clinical trial. This trial evaluates pumitamig (BNT327/BMS986545), an investigational PD-L1/VEGF-A bispecific antibody, being jointly developed by BioNTech and BMS, alone or in combination with other potential treatment options in advanced renal cell carcinoma ("RCC").
Previous report
** Study discontinued or substantially completed.
Reworded paragraphs (22)
Previous wording
The discussion contained herein and other parts of this report contain forward-looking statements that involve risk and uncertainties, such as statements of our plans, objectives, expectations, and intentions. The words "believe," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "plan," "potential," "predict," "seek," "should," "would", "advance", "future", "prepare" or the negative version of these words and similar expressions are intended to identify forward-looking statements. Such statements reflect our beliefs and opinions on the relevant subject based upon information available to us as of the date of this Quarterly Report on Form 10-Q. While we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. Our actual results could differ materially from those discussed in these forward-looking and other statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in the section of this report titled "Risk Factors."
Current wording
The discussion contained herein and other parts of this report contain forward-looking statements that involve risks and uncertainties, such as statements of our plans, objectives, expectations, and intentions. The words "believe," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "plan," "potential," "predict," "seek," "should," "would," "advance," "future," "prepare" or the negative version of these words and similar expressions are intended to identify forward-looking statements. Such statements reflect our beliefs and opinions on the relevant subject based upon information available to us as of the date of this Quarterly Report on Form 10-Q. While we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. Our actual results could differ materially from those discussed in these forward-looking and other statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in the section of this report titled "Risk Factors."
Previous wording
The following chart summarizes our current clinical and late pre-clinical stage portfolio:
Current wording
The following chart summarizes our current clinical and late preclinical stage portfolio:
Previous wording
•As announced in April 2026, Gilead’s option rights under the Gilead Collaboration Agreement entered into in 2020, as amended, ended on July 14, 2026, following Gilead’s decision not to make the option continuation payment. Accordingly, Gilead does not have option rights to additional programs in our early-stage pipeline, including the CCR6, CD89 and CD40L programs, but maintains time-limited options to programs including AB801 (an investigational small molecule AXL inhibitor), AB598 (an investigational anti-CD39 monoclonal antibody) and an investigational TNF small molecule inhibitor. Gilead’s time-limited option rights to AB102 (an investigational MRGPRX2 antagonist) have also expired.
Current wording
•As announced in April 2026, Gilead's option rights under the Gilead Collaboration Agreement entered into in 2020, as amended, ended on July 14, 2026, following Gilead's decision not to make the option continuation payment. Gilead holds time-limited options to our programs, including AB801 (an investigational small-molecule AXL inhibitor), AB598 (an investigational anti-CD39 monoclonal antibody) and an investigational TNF small-molecule inhibitor.
Previous wording
•In July 2026, we announced a clinical trial collaboration with Summit Therapeutics. Under the agreement, a new cohort in the ARC-20 platform study will evaluate casdatifan with ivonescimab, an investigational PD-1/VEGF bispecific antibody, in first-line clear cell renal cell carcinoma ("ccRCC").
Current wording
•In July 2026, we announced a clinical trial collaboration with Summit Therapeutics. Under the agreement, a new cohort in the ARC-20 platform study will evaluate casdatifan with ivonescimab, an investigational PD-1/VEGF bispecific antibody, in first-line ccRCC.
Previous wording
•In July 2026, we announced a clinical supply agreement with AVEO Oncology, an LG Chem company. Under the agreement, AVEO will supply its vascular endothelial growth factor receptor ("VEGFR") tyrosine kinase inhibitor ("TKI") tivozanib (FOTIVDA®) to be evaluated in combination with casdatifan as part of a new ARC-20 cohort in patients with advanced ccRCC previously treated with belzutifan.
Current wording
•In July 2026, we announced a clinical supply agreement with AVEO Oncology, an LG Chem company. Under the agreement, AVEO will supply its vascular endothelial growth factor receptor ("VEGFR") TKI tivozanib (FOTIVDA®) to be evaluated in combination with casdatifan as part of a new ARC-20 cohort in patients with advanced ccRCC previously treated with belzutifan.
Previous wording
•In April 2026, we announced the discontinuation of the Phase 3 STAR-121 study due to futility, and in August 2026, we announced the discontinuation of the Phase 3 PACIFIC-8 study. STAR-121 evaluated domvanalimab plus the anti-PD-1 antibody zimberelimab and chemotherapy versus pembrolizumab plus chemotherapy as a first-line treatment for metastatic NSCLC. PACIFIC-8 evaluated domvanalimab in combination with durvalumab versus durvalumab alone in patients with PD-L1 positive, Stage III unresectable NSCLC.
Current wording
•In August 2026, we announced the discontinuation of the Phase 3 PACIFIC-8 study and subsequently executed a termination agreement with AstraZeneca. PACIFIC-8 evaluated domvanalimab in combination with durvalumab versus durvalumab alone in patients with PD-L1 positive, Stage III unresectable NSCLC.
Previous wording
The level of our future R&D investment will depend on a number of factors and uncertainties including the breadth of our clinical programs, the outcome of our efforts, and our collaboration activities. We expect R&D expenses to continue to decline in the near term relative to what we have incurred as we wind down studies related to domvanalimab. Streamlining initiatives we have undertaken across our R&D operations in connection with this wind-down, together with efficiencies we are pursuing across our programs outside the Gilead collaboration, are expected to further reduce costs. These decreases will be partially offset by our increased investment in the development of casdatifan and advancement of our small-molecule immunology programs. We solely own casdatifan and lead its global development and commercialization, working with strategic partners in certain regions. As we advance our clinical-stage programs, including casdatifan, and prepare to seek regulatory approval, we may need to expand our late-stage development and commercial capabilities, which will require increased investment.
Current wording
The level of our future R&D investment will depend on a number of factors and uncertainties including the breadth of our clinical programs, the outcome of our efforts, and our collaboration activities. R&D expenses have declined as we have wound down studies related to domvanalimab, implemented streamlining initiatives across our R&D operations in connection with this wind-down and realized efficiencies across our programs outside the Gilead collaboration. We expect R&D expenses to remain relatively consistent in the near term, as increased investment in the development of casdatifan and the advancement of our small-molecule immunology programs continues to offset the decreases in our other programs. We solely own casdatifan and lead its global development and commercialization, working with strategic partners in certain regions. As we advance our clinical-stage programs, including casdatifan, and prepare to seek regulatory approval, we may need to expand our late-stage development and commercial capabilities, which will require increased investment.
Previous wording
The decrease in Total revenues for the three months ended June 30, 2026 was primarily driven by the cumulative catch-up from license and development services revenue of $143 million in 2025 due to Gilead's return of its license to the etrumadenant program, partially offset by: (i) an increase in access rights revenues recognized in the second quarter 2026 related to the expiration of Gilead's option rights; and (ii) increased revenues related to programs optioned under the Taiho Collaboration Agreement.
Current wording
The decrease in Total revenues for the nine months ended September 30, 2026 was primarily driven by (i) the cumulative catch-up from license and development services revenues of $143 million in 2025 due to Gilead's return of its license to the etrumadenant program and (ii) lower revenues related to the Gilead Collaboration Agreements as activities wind down or reach completion, partially offset by: (i) an increase in access rights revenues recognized in the second-quarter 2026 related to the expiration of Gilead's option rights; and (ii) increased revenues related to programs under the Taiho Collaboration Agreement.
Previous wording
*** Other includes ARC-7, ARC-8, ARC-9, ARC-26, EDGE-Gastric, EDGE-Lung, eVOLVE, STELLAR-009, VELOCITY-HNSCC, and VELOCITY-LUNG. These studies have been discontinued or substantially completed.
Current wording
*** Includes ARC-7, ARC-8, ARC-9, ARC-26, EDGE-Gastric, EDGE-Lung, eVOLVE, STELLAR-009, VELOCITY-HNSCC, and VELOCITY-LUNG. These studies have been discontinued, completed or substantially completed.
Previous wording
The decrease in R&D expenses for the three months ended June 30, 2026 was primarily due to: (i) late-stage development activities decreasing primarily due to the wind down of Phase 3 studies related to domvanalimab and the completion of enrollment of PRISM-1, partially offset by increasing activities in our Phase 3 studies for casdatifan; (ii) early-stage development activities decreasing primarily due to the wind down of Phase 2 studies related to domvanalimab and lower Phase 2 study costs for casdatifan; partially offset by (iii) partnership reimbursements decreasing, primarily due to Gilead-led activities representing a larger share of total joint development costs and a shift towards programs fully funded by us.
Current wording
The decrease in R&D expenses for the three months ended September 30, 2026 was primarily due to: (i) late-stage development activities decreasing primarily due to the wind-down of Phase 3 studies related to domvanalimab and the completion of enrollment of PRISM-1, partially offset by increasing activities in our Phase 3 studies for casdatifan; (ii) early-stage development activities decreasing primarily due to the wind-down of Phase 2 studies related to domvanalimab and lower Phase 2 study costs for casdatifan; partially offset by (iii) partnership reimbursements decreasing primarily due to a shift towards programs fully funded by us.
Previous wording
The decrease in R&D expenses for the six months ended June 30, 2026 was primarily due to: (i) late-stage development activities decreasing primarily due to the wind down of Phase 3 studies related to domvanalimab, partially offset by increasing activities in our Phase 3 studies for casdatifan; (ii) early-stage development activities decreasing primarily due to the wind down of Phase 2 studies related to domvanalimab and lower Phase 2 study costs for casdatifan; partially offset by (iii) partnership reimbursements decreasing, primarily due to Gilead-led activities representing a larger share of total joint development costs and a shift towards programs fully funded by us.
Current wording
The decrease in R&D expenses for the nine months ended September 30, 2026 was primarily due to: (i) late-stage development activities decreasing primarily due to the wind-down of Phase 3 studies related to domvanalimab and the completion of enrollment of PRISM-1, partially offset by increasing activities in our Phase 3 studies for casdatifan; (ii) early-stage development activities decreasing primarily due to the wind-down of Phase 2 studies related to domvanalimab and lower Phase 2 study costs for casdatifan and quemliclustat; partially offset by (iii) partnership reimbursements decreasing, primarily due to a shift towards programs fully funded by us.
Previous wording
We expect R&D expenses to continue to decline in the near term relative to what we have incurred as we wind down studies related to domvanalimab. Streamlining initiatives we have undertaken across our R&D operations in connection with this wind-down, together with efficiencies we are pursuing across our programs outside the Gilead collaboration, are expected to further reduce costs. These decreases will be partially offset by our increased investment in the development of casdatifan and advancement of our small-molecule immunology programs.
Current wording
R&D expenses have declined as we have wound down studies related to domvanalimab, implemented streamlining initiatives across our R&D operations in connection with this wind-down and realized efficiencies across our programs outside the Gilead collaboration. We expect R&D expenses to remain relatively consistent in the near term, as increased investment in the development of casdatifan and the advancement of our small-molecule immunology programs continues to offset the decreases in our other programs.
Previous wording
The decrease in G&A expenses for the six months ended June 30, 2026, was primarily due to streamlining initiatives we have undertaken across our operations.
Current wording
The decrease in G&A expenses for the nine months ended September 30, 2026, was primarily due to streamlining initiatives we have undertaken across our operations.
Previous wording
The decrease in Non-operating income, net for the six months ended June 30, 2026, was primarily due to: lower yields and a lower average balance for our investment portfolio; and higher interest expense on our long-term debt due to the additional drawdown under our agreement with Hercules at the end of the second quarter 2025.
Current wording
The decrease in Non-operating income, net for the three months ended September 30, 2026, was primarily due to: lower yields and a lower average balance for our investment portfolio.
Previous wording
The decrease in Non-operating income, net for the three months ended June 30, 2026, was primarily due to: lower yields and a lower average balance for our investment portfolio; and higher interest expense on our long-term debt due to the additional drawdown under our agreement with Hercules at the end of the second quarter 2025.
Current wording
The decrease in Non-operating income, net for the nine months ended September 30, 2026, was primarily due to: lower yields and a lower average balance for our investment portfolio; and higher interest expense on our long-term debt due to the additional drawdown under our agreement with Hercules at the end of the second-quarter 2025.
Previous wording
There was no Income tax expense for the three and six months ended June 30, 2026 or 2025 due to forecasted full year NOLs. We are currently under U.S. IRS examination for the 2023 tax year. We do not expect the examination to have a material impact on our liquidity, capital resources, or results of operations; however, the examination remains ongoing and the ultimate outcome cannot be predicted with certainty.
Current wording
There was no Income tax expense for the three and nine months ended September 30, 2026 or 2025 due to forecasted full year NOLs. We are currently under U.S. IRS examination for the 2023 tax year. We do not expect the examination to have a material impact on our liquidity, capital resources, or results of operations; however, the examination remains ongoing and the ultimate outcome cannot be predicted with certainty.
Previous wording
Our cash and investments are held in a variety of interest-bearing instruments, including money market funds, U.S. government treasury and agency obligations, investments in corporate securities and certificates of deposit. Based on our existing business plan, we believe that our cash, cash equivalents, and marketable securities as of June 30, 2026 will be sufficient to fund our planned level of operations until at least the second half of 2028.
Current wording
Our cash and investments are held in a variety of interest-bearing instruments, including money market funds, U.S. government treasury and agency obligations, investments in corporate securities and certificates of deposit. Based on our existing business plan, we believe that our cash, cash equivalents, and marketable securities as of September 30, 2026, together with the proceeds from our equity financing in October 2026, will be sufficient to fund our planned level of operations into 2029.
Previous wording
Net cash used in operating activities was $257 million for the six months ended June 30, 2026 compared to $265 million for the same period in the prior year. The change in operating cash flows is primarily due to the timing of receipts from Taiho for development milestones.
Current wording
Net cash used in operating activities was $345 million for the nine months ended September 30, 2026 compared to $362 million for the same period in the prior year. The change in operating cash flows is primarily due to the timing of receipts from Taiho for development milestones.
Previous wording
Cash provided by investing activities for the six months ended June 30, 2026 was primarily due to net proceeds from marketable securities of $166 million.
Current wording
Cash provided by investing activities for the nine months ended September 30, 2026 was primarily due to net proceeds from marketable securities of $248 million.
Previous wording
Cash provided by investing activities for the six months ended June 30, 2025 was primarily due to net proceeds from marketable securities of $170 million.
Current wording
Cash provided by investing activities for the nine months ended September 30, 2025 was primarily due to net proceeds from marketable securities of $249 million.
Previous wording
Cash provided by financing activities for the six months ended June 30, 2026 was due to proceeds of $19 million for stock issued under our equity award plans.
Current wording
Cash provided by financing activities for the nine months ended September 30, 2026 was due to proceeds of $26 million for stock issued under our equity award plans.
Previous wording
Cash provided by financing activities for the six months ended June 30, 2025 was due to net proceeds of $142 million from issuance of our common stock under the February 2025 underwritten offering and $49 million from our borrowings under the Hercules Agreement.
Current wording
Cash provided by financing activities for the nine months ended September 30, 2025 was due to net proceeds of $150 million from issuance of our common stock, primarily due to the February 2025 underwritten offering, and $49 million from our borrowings under the Hercules Agreement and proceeds of $3 million for stock issued under our equity award plans.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
The decrease in Total revenues for the three months ended September 30, 2026 was primarily driven by lower revenues related to the Gilead Collaboration Agreements as activities wind down or reach completion, partially offset by increased revenues related to programs under the Taiho Collaboration Agreement.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
The decrease in Total revenues for the six months ended June 30, 2026 was primarily driven by the cumulative catch-up from license and development services revenue of $143 million in 2025 due to Gilead's return of its license to the etrumadenant program, partially offset by: (i) an increase in access rights revenues recognized in the second quarter 2026 related to the expiration of Gilead's option rights; and (ii) increased revenues related to programs optioned under the Taiho Collaboration Agreement.