Arcus Biosciences, Inc.: Q4 FY2025 earnings call

What management said about Q4 FY2025, from the documents filed with the SEC on 25 February 2026: press release. Guidance figures: 1 new. The quarter’s numbers.

Key takeaways

Full-year revenue of $247 million: Full-year 2025 revenue was $247 million, compared with the $225 million to $235 million range given in the third-quarter release. Full-year 2024 revenue was $258 million. Source
Fourth-quarter net loss of $106 million: Net loss was $106 million for the fourth quarter, against $94 million a year earlier. Full-year net loss was $353 million, or $3.29 per basic and diluted share. Source
100mg cohort response rate 45.2%: In the 100mg once-daily cohort, confirmed response rate rose to 45.2% and median PFS was 15.1 months, with 17.9 months of median follow-up at a January 30, 2026 cutoff. Source
Zimberelimab cohort fully enrolled: Casdatifan plus zimberelimab in ARC-20 has completed enrollment. Arcus expects this combination to be the backbone of its front-line strategy. Source
Domvanalimab Phase 3 and Phase 2 wind-down: Arcus and Gilead are winding down activities for the Phase 3 STAR-221 and Phase 2 EDGE-Gastric studies of domvanalimab plus zimberelimab. Source
STAR-121 futility analysis due: A futility analysis of the Phase 3 STAR-121 lung cancer study is planned in the coming months. Its result will set next steps for the domvanalimab program. Source
MRGPRX2 oral antagonist to enter clinic: Arcus expects its first inflammation program, an oral MRGPRX2 antagonist for atopic dermatitis and chronic spontaneous urticaria, to enter clinical development in 2026. Source
R&D up on Phase 3 spending: Fourth-quarter R&D was $121 million, up $10 million, from higher late-stage costs for casdatifan and quemliclustat Phase 3 studies, partly offset by lower early-stage costs. Source
Cash position of $1.0 billion: Cash, cash equivalents and marketable securities were $1.0 billion at December 31, 2025, up from $992 million a year earlier. Source

“This week’s updated data at ASCO GU continue to validate casdatifan’s profile as the best-in-class HIF-2a inhibitor and new potential standard-of-care therapy for ccRCC”
Terry Rosen, Ph.D., chief executive officer of Arcus

Guidance

Area	Period	Figure	Against last quarter
GAAP revenue Source	full year 2026	$45 to $55 million	New
Cash runway Source	funding horizon	until at least the second half of 2028

What changed from last quarter

New guidance: Full-year 2026 GAAP revenue guidance of $45 million to $55 million was given. Source
New guidance: Full-year 2026 R&D expense guidance: a meaningful decrease from 2025. Source
New: First-line registrational strategy is now TKI-free. The Phase 3 start target moved from early-line in second half 2026 to first-line by end of 2026. Source
Ended: Arcus and Gilead are winding down activities for the Phase 3 STAR-221 and Phase 2 EDGE-Gastric domvanalimab studies. Source

Fourth-quarter and full-year results

Full-year revenue of $247 million: Full-year 2025 revenue was $247 million, compared with the $225 million to $235 million range given in the third-quarter release. Full-year 2024 revenue was $258 million. Source
Fourth-quarter revenue sources named: Fourth-quarter revenue was $33 million, against $36 million a year earlier. It included $23 million from the Gilead collaboration, $7 million from Taiho's casdatifan option, and $3 million from Gilead pipeline access rights. Source
Fourth-quarter net loss of $106 million: Net loss was $106 million for the fourth quarter, against $94 million a year earlier. Full-year net loss was $353 million, or $3.29 per basic and diluted share. Source

Casdatifan kidney cancer data

100mg cohort response rate 45.2%: In the 100mg once-daily cohort, confirmed response rate rose to 45.2% and median PFS was 15.1 months, with 17.9 months of median follow-up at a January 30, 2026 cutoff. Source
Pooled late-line response rate 34.7%: In the pooled analysis of 121 patients, confirmed response rate increased to 34.7% and median PFS was stable at 12.2 months, with 20.8 months of median follow-up. Source
Biomarker linked to clinical benefit: Biomarker data linked the level and durability of erythropoietin suppression to clinical benefit, including primary progression rate, response rate and PFS. Source
Safety profile unchanged: The company said the casdatifan safety profile remained consistent with prior analyses. Source
PEAK-1 Phase 3 now enrolling globally: PEAK-1 is a Phase 3 study of casdatifan plus cabozantinib versus cabozantinib in IO-experienced metastatic ccRCC. It started enrollment in 3Q25 and is now enrolling globally. Source

“We are focused on rapidly enrolling PEAK-1, our Phase 3 study evaluating casdatifan plus cabozantinib in IO-experienced patients”
Terry Rosen, Ph.D., chief executive officer of Arcus

First-line kidney cancer strategy

Zimberelimab cohort fully enrolled: Casdatifan plus zimberelimab in ARC-20 has completed enrollment. Arcus expects this combination to be the backbone of its front-line strategy. Source
Ipilimumab combination cohort enrolling: Arcus is enrolling a cohort of casdatifan plus zimberelimab and ipilimumab as part of ARC-20. Source
Volrustomig combination run by AstraZeneca: Casdatifan plus volrustomig is being evaluated in eVOLVE-RCC02, which AstraZeneca is operationalizing. Source
Further combinations planned this year: This year Arcus plans to test casdatifan in at least one more first-line combination and in one other tumor type. Source

Domvanalimab and quemliclustat programs

Domvanalimab Phase 3 and Phase 2 wind-down: Arcus and Gilead are winding down activities for the Phase 3 STAR-221 and Phase 2 EDGE-Gastric studies of domvanalimab plus zimberelimab. Source
STAR-121 futility analysis due: A futility analysis of the Phase 3 STAR-121 lung cancer study is planned in the coming months. Its result will set next steps for the domvanalimab program. Source
PRISM-1 enrollment finished: Enrollment finished in September 2025 for PRISM-1, the Phase 3 quemliclustat trial in first-line metastatic pancreatic cancer. Source

“We remain extremely well-positioned to execute on our casdatifan program and our emerging inflammation portfolio, with cash runway until at least the second half of 2028.”
Terry Rosen, Ph.D., chief executive officer of Arcus

Inflammation and immunology programs

MRGPRX2 oral antagonist to enter clinic: Arcus expects its first inflammation program, an oral MRGPRX2 antagonist for atopic dermatitis and chronic spontaneous urticaria, to enter clinical development in 2026. Source
MRGPRX2 designed for lower exposure: The molecule is designed for high potency, so maximal pharmacology is reached at substantially lower exposure than the most advanced MRGPRX2 antagonist in clinical development. Source
Oral TNF inhibitor nearing clinic: An oral small-molecule TNF inhibitor for rheumatoid arthritis, psoriasis and inflammatory bowel disease is expected to enter the clinic in late 2026 or early 2027. Source
TNFR1 selectivity targeted: The TNF molecules are designed to selectively block TNFR1 signaling, aiming at better safety and efficacy than approved anti-TNF antibodies. Source

Operating costs and reimbursements

R&D up on Phase 3 spending: Fourth-quarter R&D was $121 million, up $10 million, from higher late-stage costs for casdatifan and quemliclustat Phase 3 studies, partly offset by lower early-stage costs. Source
Full-year R&D and G&A totals: Full-year 2025 R&D expenses were $523 million, against $448 million in 2024. Full-year G&A expenses were $110 million, against $120 million. Source
Reimbursements fell on Gilead-led spend: Gross reimbursements for shared collaboration costs were $127 million in 2025, against $165 million in 2024. The company attributed the decline to a larger Gilead-led share of joint costs. Source
Fourth-quarter G&A of $26 million: G&A expenses were $26 million for the quarter, against $28 million a year earlier. Non-cash stock-based compensation within G&A was $7 million. Source

Cash, funding and runway

Cash position of $1.0 billion: Cash, cash equivalents and marketable securities were $1.0 billion at December 31, 2025, up from $992 million a year earlier. Source
Equity and loan drove cash increase: The increase reflects $429 million in net proceeds from common stock issuances, a further $50 million term loan drawdown, and $37 million from Taiho for milestones and option payments. Source
Cash used in R&D offset gains: The increase was partly offset by cash used in research and development activities. Source

Coming up, as management said on 25 February 2026

Two casdatifan data presentations in 2026: Updated casdatifan plus cabozantinib data and initial early-line data are expected as at least two presentations in 2026. Source
Mature cabozantinib cohort data: Mature ORR and initial PFS data for about 45 patients will be presented at an investor event or medical conference, with at least 12 months of follow-up. Source
Zimberelimab cohort data in second half: Data from the casdatifan plus zimberelimab cohort are planned for the second half of 2026. Source
First-line Phase 3 start by end 2026: A Phase 3 study of a TKI-free casdatifan combination in first-line metastatic kidney cancer is planned to start by the end of 2026. Source
Quemliclustat PRISM-1 results in 2027: Results from the PRISM-1 Phase 3 quemliclustat study are expected in the first half of 2027. Source
MRGPRX2 proof-of-concept data possible: After a first-in-human healthy volunteer study, a proof-of-concept study could yield data within a year of clinic entry. Source

Figures management reported

Figure	Reported
R&D expenses, fourth quarter 2025 Source	$121 million
R&D expenses, full year 2025 Source	$523 million
Casdatifan cORR and mPFS, 100mg QD cohort Source	45.2% and 15.1 months
Casdatifan pooled cORR, n=121 Source	34.7%
PRISM-1 Phase 3 enrollment Source	completed September 2025
STAR-121 futility analysis timing Source	in the next couple of months

Risks management discussed

Financial: The size of the 2026 R&D decrease depends on the STAR-121 futility analysis result. Source
Financial: Partnership reimbursements fell as Gilead-led activities took a larger share of joint development costs. Source
Operational: Winding down domvanalimab Phase 3 and Phase 2 activities removes two upper GI cancer studies from the program. Source
Operational: Speed of PEAK-1 enrollment is a stated management focus for the casdatifan Phase 3 program. Source

Earlier plans management reported on

Not stated: The third-quarter release gave a full-year 2025 revenue range. The fourth-quarter release reports $247 million for the year.
Not stated: The third-quarter release expected R&D to decline from fourth quarter 2025. The fourth-quarter release reports R&D up year on year.
Met: Enrollment in the casdatifan plus zimberelimab cohort of ARC-20 is complete. Source
Not stated: The third-quarter release targeted an early-line Phase 3 start in second half 2026. The fourth-quarter release gives an end-2026 first-line TKI-free goal.

Other quarters

Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.

As filed with the SEC

Open the filing on EDGAR

Arcus Biosciences Reports Fourth-Quarter and Full-Year 2025 Financial Results and Provides a Pipeline Update

Updated data for casdatifan in late-line kidney cancer demonstrated median progression-free survival (PFS) of 15.1 months and a confirmed overall response rate (cORR) of 45% for the 100mg once-daily (QD) cohort
At least two additional data presentations for casdatifan are expected in 2026: updated data for casdatifan plus cabozantinib and initial data in early-line kidney cancer
In addition to the ongoing Phase 3 PEAK-1 study, Arcus plans to initiate a Phase 3 study in the first-line (1L) metastatic setting evaluating casdatifan in a tyrosine kinase inhibitor (TKI)-free combination by the end of 2026
With $1.0 billion in cash, cash equivalents and marketable securities at year-end, Arcus is well positioned to advance casdatifan with cash runway until at least the second half of 2028

HAYWARD, Calif. - (BUSINESS WIRE) - Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for patients with cancer and inflammatory and autoimmune diseases, today reported financial results for the year and quarter ended December 31, 2025, and provided a pipeline update on its clinical-stage investigational molecules and discovery programs.

“This week’s updated data at ASCO GU continue to validate casdatifan’s profile as the best-in-class HIF-2a inhibitor and new potential standard-of-care therapy for ccRCC,” said Terry Rosen, Ph.D., chief executive officer of Arcus. “We are focused on rapidly enrolling PEAK-1, our Phase 3 study evaluating casdatifan plus cabozantinib in IO-experienced patients, as well as determining the optimal TKI-free casdatifan-based regimen for a registrational trial in the 1L setting by the end of the year. Together, the IO-experienced and first line settings represent an over $5 billion peak sales opportunity for casdatifan. We remain extremely well-positioned to execute on our casdatifan program and our emerging inflammation portfolio, with cash runway until at least the second half of 2028.”

Casdatifan (HIF-2a inhibitor)

Recent Data Update:

Earlier this week, Arcus shared updated ORR and PFS data from the cohorts of the Phase 1/1b ARC-20 study evaluating casdatifan monotherapy in late-line ccRCC. These data will be presented by Dr. Toni Choueiri of the Dana-Farber Cancer Institute at ASCO GU on February 28, 2026.
In the 100mg QD cohort, with 17.9 months of median follow up, cORR increased to 45.2% with an mPFS of 15.1 months as of the data cut-off (DCO) date of January 30, 2026.
In the pooled analysis (n=121), with 20.8 months of median follow up, cORR increased to 34.7% and mPFS was stable at 12.2 months as of the DCO.
New biomarker data demonstrated a strong correlation between the magnitude and durability of erythropoietin suppression by casdatifan and clinical benefit, including rate of primary progression, cORR and PFS.
The safety profile of casdatifan remained consistent with prior analyses.

Casdatifan Development Program:

IO-experienced ccRCC: PEAK-1, a Phase 3 study evaluating casdatifan + cabozantinib versus cabozantinib in immunotherapy (IO)-experienced metastatic ccRCC, started enrollment in 3Q25 and is now enrolling globally.
1L ccRCC: Arcus is focused on TKI-free regimens, which are enabled by the consistently low rate of primary progression observed with casdatifan across all cohorts and settings evaluated to date. Emerging data from the following cohorts are designed to determine the optimal 1L registrational strategy with the goal of initiating a Phase 3 study by the end of 2026:
Casdatifan plus zimberelimab (Arcus’s anti-PD-1 antibody) and ipilimumab: Arcus is now enrolling a cohort evaluating this combination as part of ARC-20.
Casdatifan plus zimberelimab: The cohort evaluating this combination in ARC-20 has completed enrollment. Arcus plans to present data from this cohort in the second half of 2026. Arcus expects this to be the backbone of its front-line strategy.
Casdatifan plus volrustomig (AstraZeneca’s anti-PD-1/CTLA-4 bispecific antibody): This combination is being evaluated in the eVOLVE-RCC02 study (which is being operationalized by AstraZeneca).
Additional combinations in ccRCC and tumor types: This year, Arcus plans to evaluate the potential of casdatifan in at least one additional combination in 1L ccRCC and in another tumor type.

Planned Data Readouts:

Arcus expects to have at least two data readouts for casdatifan in 2026:

More mature ORR data and initial PFS data for approximately 45 patients treated in the ARC-20 cohort evaluating casdatifan plus cabozantinib in the IO-experienced setting will be presented at an investor event or at a medical conference. All patients will have had at least 12 months of follow-up.
Initial data from the ARC-20 cohorts evaluating casdatifan in early-line settings, including the cohort evaluating casdatifan plus zimberelimab in 1L ccRCC.

Quemliclustat (small-molecule CD73 inhibitor)

Enrollment was completed for PRISM-1, a Phase 3 trial of quemliclustat combined with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel in 1L metastatic pancreatic ductal adenocarcinoma, in September 2025. Results from this study are expected in the first half of 2027.

Emerging I&I Portfolio

Arcus expects to advance its first inflammation program, a potential best-in-class oral MRGPRX2 antagonist for atopic dermatitis and chronic spontaneous urticaria, into clinical development in 2026.
The molecule was designed to have exquisite potency, enabling the ability to elicit maximal pharmacology at substantially lower exposure relative to the most advanced MRGPRX2 antagonist in clinical development, thereby avoiding potential exposure-limiting toxicities.
Clinical development will begin with a first-in-human healthy volunteer study followed quickly by a proof-of-concept study, with potential for data within a year from entry into the clinic.
Arcus also expects to advance an oral small-molecule TNF inhibitor, a potential treatment for rheumatoid arthritis, psoriasis and inflammatory bowel disease, into the clinic in late 2026 or early 2027.
The molecules are being designed to selectively block TNFR1 signaling in order to achieve better safety and efficacy than approved anti-TNF antibodies.

Domvanalimab (Fc-silent anti-TIGIT antibody) plus Zimberelimab (anti-PD-1 antibody)

Status Update:

Arcus and Gilead are in the process of rapidly winding down activities related to the Phase 3 STAR-221 and Phase 2 EDGE-Gastric studies.
A futility analysis of STAR-121, a Phase 3 study evaluating domvanalimab plus zimberelimab and chemotherapy in 1L non-small cell lung cancer, will be conducted in the next couple of months to determine next steps for the program.

Financial Results for Fourth Quarter and Full Year 2025:

Cash, Cash Equivalents and Marketable Securities were $1.0 billion as of December 31, 2025, compared to $992 million as of December 31, 2024. The increase is primarily due to $429 million in net proceeds from issuances of our common stock, the additional $50 million drawdown under our term loan facility, and $37 million from Taiho for development milestones and option payments, partially offset by cash used in research and development activities. Arcus expects its cash and investments will be sufficient to provide funding until at least the second half of 2028.
Revenues were $33 million for the fourth quarter 2025, compared to $36 million for the same period in 2024. Fourth quarter 2025 revenues included (i) $23 million related to programs under the Gilead collaboration, (ii) $7 million related to Taiho's exercise of its option to casdatifan, and (iii) $3 million related to Gilead’s ongoing rights to access Arcus’s research and development pipeline. GAAP revenue for the full year 2026 is expected to be between $45 to $55 million.
Research and Development (R&D) Expenses were $121 million for the fourth quarter 2025, compared to $111 million for the same period in 2024. The net increase of $10 million was primarily attributable to higher late-stage development costs, driven by increased enrollment and clinical activities in our Phase 3 studies for casdatifan and quemliclustat, partially offset by lower early-stage development costs, as earlier study activities for domvanalimab and etrumadenant approached completion. For the fourth quarter 2025 and 2024, Arcus recognized gross reimbursements of $28 million and $41 million, respectively, for shared collaboration expenses, primarily from Gilead. Gross reimbursements were $127 million for the full year 2025, compared to $165 million for 2024. Our partnership reimbursements decreased compared to the prior year, primarily due to Gilead-led activities representing a larger share of total joint development costs and an increase in programs fully funded by us. R&D expenses are expected to decrease meaningfully for the full year 2026 relative to 2025; the magnitude of the decrease will be determined in part by the results of the futility analysis of STAR-121. Non-cash stock-based compensation expense was $8 million for each of the fourth quarter 2025 and 2024.
General and Administrative (G&A) Expenses were $26 million for the fourth quarter 2025, compared to $28 million for the same period in 2024. Non-cash stock-based compensation expense was $7 million for the fourth quarter 2025, compared to $9 million for the same period in 2024.
Net Loss was $106 million for the fourth quarter 2025, compared to $94 million for the same period in 2024.

Conference Call Information:

Arcus will host a conference call and webcast today, February 25, 2026, at 1:30 PM PT/4:30 PM ET to discuss its fourth-quarter and full-year 2025 financial results and pipeline updates. To access the call, please dial +1 (646) 844-6383 (local) or +1 (833) 470-1428 (toll-free), using Access Code: 190500. Participants may also register for the call online using the following link: https://events.q4inc.com/attendee/640976415. To access the live webcast and accompanying slide presentation, please visit the “Investors & Media” section of the Arcus Biosciences website at www.arcusbio.com. A replay of the webcast will be available following the live event.

About Arcus Biosciences

Arcus Biosciences is a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules for the treatment of cancer and inflammatory and autoimmune diseases. In partnership with industry collaborators, patients and physicians around the world, Arcus is expediting the development of its late-stage portfolio of first- and/or best-in-class medicines against well-characterized biological targets and pathways and studying novel, biology-driven combinations that have the potential to help people with cancer live longer. Founded in 2015, the company has advanced multiple investigational medicines into registrational clinical trials including casdatifan, a HIF-2a inhibitor for clear cell renal cell carcinoma, and quemliclustat, a small-molecule CD73 inhibitor for pancreatic cancer. For more information about Arcus Biosciences’ clinical and preclinical programs, please visit www.arcusbio.com.

Forward-Looking Statements

Forward-looking statements notice

This press release 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, the timing of milestones, including future data presentations, initiation of new cohorts and clinical studies and completion of enrollment for ongoing studies; potential for casdatifan to become a standard-of-care therapy; and advantages of Arcus’s inflammation and immunology programs. All forward-looking statements involve known and unknown risks and uncertainties and other important factors that may cause Arcus’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 guarantees of future data or replicated in other studies evaluating casdatifan, including the Phase 3 PEAK-1 study; the unexpected emergence of adverse events or other undesirable side effects with casdatifan; risks associated with manufacturing or supplying product for clinical trials evaluating casdatifan; adverse data from toxicology studies that affect Arcus’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 Arcus’s programs; and the inherent uncertainty associated with pharmaceutical product development and clinical trials. Risks and uncertainties facing Arcus are described more fully in the “Risk Factors” section of Arcus’s most recent periodic report filed with the U.S. Securities and Exchange Commission (SEC) and in other filings that Arcus makes with the SEC from time to time, which are available at www.sec.gov. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Arcus disclaims any obligation or undertaking to update, supplement or revise any forward-looking statements contained in this press release, except to the extent required by law.

The Arcus name and logo are trademarks of Arcus Biosciences, Inc. All other trademarks belong to their respective owners.

Investor Inquiries:

Pia Eaves VP of Investor Relations & Strategy (617) 459-2006 peaves@arcusbio.com

Media Inquiries:

Holli Kolkey VP of Corporate Affairs (650) 922-1269 hkolkey@arcusbio.com

Maryam Bassiri

AD, Corporate Communications

(510) 406-8520 mbassiri@arcusbio.com

ARCUS BIOSCIENCES, INC.

Consolidated Statements of Operations

(unaudited)

(In millions, except per share amounts)

	Three Months Ended December 31,				Years Ended December 31,
	2025		2024		2025		2024
Revenues:
License and development service	$29		$28		$221		$222
Other collaboration	4		8		26		36
Total revenues	33		36		247		258
Operating expenses:
Research and development	121		111		523		448
General and administrative	26		28		110		120
Impairment of long-lived assets	-		-		-		20
Total operating expenses	147		139		633		588
Loss from operations	(114)		(103)		(386)		(330)
Non-operating income (expense):
Interest and other income, net	10		12		41		52
Interest expense	(2)		(2)		(8)		(4)
Total non-operating income, net	8		10		33		48
Loss before income taxes	(106)		(93)		(353)		(282)
Income tax expense	-		(1)		-		(1)
Net loss	$(106)		$(94)		$(353)		$(283)
Net loss per share:
Basic and diluted	$(0.89)		$(1.03)		$(3.29)		$(3.14)
Shares used to compute net loss per share:
Basic and diluted		118.5		91.7		107.4		90.1

Selected Consolidated Balance Sheet Data

(unaudited)

(In millions)

	December 31, 2025	December 31, 2024
Cash, cash equivalents and marketable securities	$1,010	$992
Total assets	1,139	1,150
Total liabilities	508	665
Total stockholders’ equity	631	485

Derived from the audited financial statements included in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 25, 2026.