Full Press Release Details
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-2ainhibitor)
Recent Data Update:
Casdatifan Development Program:
Planned Data Readouts:
Arcus expects to have at least two data readouts for casdatifan in 2026:
Quemliclustat (small-molecule CD73 inhibitor)
Emerging I&I Portfolio
Domvanalimab (Fc-silent anti-TIGIT antibody) plus Zimberelimab (anti-PD-1 antibody)
Status Update:
Financial Results for Fourth Quarter and Full Year 2025:
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 atwww.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 visitwww.arcusbio.com.
Forward-Looking Statements
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 atwww.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.
| ARCUS BIOSCIENCES, INC.Consolidated Statements of Operations(unaudited)(In millions, except per share amounts) | |||||||||||||||
| Three Months EndedDecember 31, | Years EndedDecember 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. |