Arcus Biosciences Inc【RCUS】株式ニュース

Arcus Biosciences Reports First-Quarter 2026 Financial Results and Provides a Pipeline UpdateMay 5, 2026 4:05 PM
Business Wire Arcus outlines development strategy to establish casdatifan as a backbone therapy across each line of treatment for clear cell renal cell carcinoma (ccRCC), including the potential to become the first HIF-2a inhibitor-based tyrosine kinase inhibitor (TKI)-free regimen in the first-line (1L) setting Phase 3 PEAK-1 study is enrolling in immunotherapy (IO)-experienced patients with ccRCC, with enrollment completion and the initiation of a 1L Phase 3 study both expected by year-end 2026 Arcus selected its first inflammation program clinical candidate AB102, an MRGPRX2 antagonist, which is expected to enter the clinic in the third quarter of 2026; its preclinical profile will be presented in an oral presentation at the Society for Investigative Dermatology Annual Meeting in May With $876 million in cash, cash equivalents and marketable securities at quarter-end, Arcus is well positioned to advance casdatifan aggressively, with cash runway until at least the second half of 2028 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for people with cancer and inflammatory and autoimmune diseases, today reported financial results for the first quarter ended March 31, 2026 and provided a pipeline update on its clinical-stage investigational molecules and discovery programs. “Arcus is entering a new era, with a clear path for casdatifan to be both first and best in the first-line setting, and a portfolio of wholly owned molecules for inflammation and immunology that provide a new strategic optionality as they move into and through development,” said Terry Rosen, Ph.D., chief executive officer of Arcus. “Our highest priority is to establish casdatifan as a foundational standard of care in kidney cancer so that patients have the opportunity to benefit from casdatifan-based regimens across lines of treatment.” Arcus is focused on completing enrollment for PEAK-1 and initiating a Phase 3 study in the 1L setting, where casdatifan has the potential to become the first HIF-2a inhibitor-based, TKI-free option, by year-end 2026. Casdatifan (HIF-2a inhibitor) Casdatifan Development Program: Arcus’s development strategy is designed to generate evidence to secure casdatifan as a backbone therapy in ccRCC so that every patient has the opportunity to benefit from casdatifan across each line of therapy over the course of their care. The company is aggressively executing on a holistic strategy to embed casdatifan into the treatment paradigm, including in combination with the most commonly used regimen in the 1L setting, anti-PD-1 plus anti-CTLA-4. Arcus is now enrolling a cohort in the Phase 1/1b ARC-20 study to generate the dataset that will support the initiation of the corresponding Phase 3 study at year-end 2026. Arcus’s choice of combination partners has been designed to complement this casdatifan-IO regimen, which has the opportunity to be the first and only such HIF-2a inhibitor-based TKI-sparing 1L therapy, with consecutive treatments with casdatifan-containing regimens in first-, second- and third-line-plus settings. In this context, Arcus will also begin to evaluate casdatifan plus TKI-containing regimens in 1L and late-line settings, the latter in both HIF-2a inhibitor-experienced and HIF-2a inhibitor-naive patients. IO-experienced ccRCC: Enrollment in PEAK-1, the global Phase 3 study evaluating casdatifan plus cabozantinib versus cabozantinib in IO-experienced metastatic ccRCC, is accelerating, and Arcus is on track to complete enrollment by year-end 2026. 1L ccRCC: Arcus has been focused on the evaluation of casdatifan-based TKI-free regimens, which have demonstrated a consistently low rate of primary progression across all cohorts and settings evaluated to date. Most notably, casdatifan plus zimberelimab (anti-PD-1) showed a primary progression rate of 7% (2 of 30 patients), comparing quite favorably to published rates observed with anti-PD-1 monotherapy or ipilimumab (anti-CTLA-4) plus nivolumab (anti-PD-1) in the 1L setting. This ARC-20 cohort is fully enrolled. A cohort evaluating casdatifan plus zimberelimab and ipilimumab in ARC-20 is currently enrolling, with the purpose of supporting Arcus’s first Phase 3 study in the 1L setting. Planned Data Readouts: Arcus expects to have multiple data readouts for casdatifan in 2026: More mature overall response rate data and initial progression-free survival 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. Updated data from ARC-20 late-line monotherapy cohorts including overall survival (OS) data. 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. Domvanalimab (Fc-silent anti-TIGIT antibody) plus Zimberelimab (anti-PD-1 antibody) Status Update: In April 2026, Arcus announced the discontinuation of the Phase 3 STAR-121 study evaluating domvanalimab plus zimberelimab and chemotherapy versus pembrolizumab plus chemotherapy as a 1L treatment for metastatic non-small cell lung cancer (NSCLC), based on the recommendation from the Independent Data Monitoring Committee following its review of data from a pre-planned futility analysis. At the futility analysis, the domvanalimab-based combination did not improve OS relative to that observed with pembrolizumab plus chemotherapy. STAR-121, along with the Phase 2 EDGE-Lung study, will be discontinued. STAR-121 also evaluated zimberelimab plus chemotherapy as an exploratory endpoint. Zimberelimab plus chemotherapy performed consistently with respect to OS as compared to pembrolizumab plus chemotherapy. Emerging I&I Portfolio AB102, a highly selective, oral MRGPRX2 antagonist and potential best-in-class treatment for atopic dermatitis and chronic spontaneous urticaria, is expected to enter the clinic in the third quarter of 2026. In May, Arcus will present the preclinical profile for AB102 in an oral presentation at the Society for Investigative Dermatology Annual Meeting, highlighting its ability to fully block MRGPRX2-dependent degranulation and transcriptional activation in LAD2 and primary skin mast cells and its inhibition of all common human MRGPRX2 variants. Clinical development will begin with a first-in-human healthy volunteer study followed by a proof-of-concept study, with potential for proof-of-concept data in early 2027. Arcus has selected a development candidate for an oral small-molecule TNF inhibitor, a potential treatment for rheumatoid arthritis, psoriasis and inflammatory bowel disease, and expects it to enter the clinic in early 2027. The molecule is designed to selectively block TNFR1 signaling. It is believed that this could lead to better safety and efficacy than those of approved anti-TNF antibodies that block both TNFR1 and TNFR2 signaling, the latter of which can paradoxically lead to an inflammatory response in some patients. Arcus has also selected an orally active small-molecule antagonist of CCR6 as a development candidate for potential treatment of psoriasis and expects it to enter the clinic in the first half of 2027. Financial Results for First Quarter 2026: Cash, Cash Equivalents and Marketable Securities were $876 million as of March 31, 2026, compared to $1.0 billion as of December 31, 2025. The decrease during the period is primarily due to the use of cash in our research and development activities. Based on our existing business plan, we believe that our cash, cash equivalents and marketable securities will be sufficient to fund our planned level of operations until at least the second half of 2028. We also expect to end 2026 with approximately $600 million in cash. Revenues were $17 million for the first quarter 2026, compared to $28 million for the same period in 2025. The decrease in revenue was primarily driven by lower development services revenue from the Gilead collaboration. Revenues reflect the recognition of payments previously received from our collaboration partners as we satisfy underlying performance obligations over time, and fluctuate each period based on our estimated progress toward completing those obligations rather than on the timing of cash receipts. Arcus expects to recognize GAAP revenue of between $50 million and $65 million for the full year 2026. Research and Development (R&D) Expenses were flat for the first quarter 2026, with (i) late-stage development programs increasing due to our investment in casdatifan and our Phase 3 PRISM-1 study for quemliclustat, partially offset by the wind-down of studies related to domvanalimab, (ii) early-stage development activities decreasing primarily due to the absence of prior-year Phase 2 study costs for domvanalimab, and (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. Non-cash stock-based compensation expense was $9 million for the first quarter 2026, compared to $8 million for the same period in 2025. For the first quarters 2026 and 2025, Arcus recognized gross reimbursements of $19 million and $38 million, respectively, for shared expenses from its collaborations. R&D expenses by quarter may fluctuate due to the timing of clinical manufacturing and standard-of-care therapeutic purchases with a corresponding impact on reimbursements. We expect R&D expenses to decline in the near term relative to what we have incurred as we wind down studies for 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 inflammation and immunology programs. General and Administrative (G&A) Expenses were $29 million for the first quarter 2026, compared to $28 million for the same period in 2025. The increase was primarily due to an increase in non-cash stock-based compensation, which was primarily attributable to a separation agreement with an officer. Non-cash stock-based compensation expense was $10 million for the first quarter 2026, compared to $8 million for the same period in 2025. Net Loss was $128 million for the first quarter 2026, compared to $112 million for the same period in 2025. Conference Call Information: Arcus will host a conference call and webcast today, May 5, 2026, at 1:30 PM PT/4:30 PM ET to discuss its first-quarter 2026 financial results and pipeline updates. To access the call, please dial +1 (585) 542-9983 (local) or +1 (833) 461-5787 (toll-free), using Meeting ID: 304747896. Participants may also register for the call online using the following link: https://events.q4inc.com/attendee/304747896. 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 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, statements regarding Arcus’s development strategies and opportunities, including the potential for casdatifan to become the first and only HIF-2a inhibitor-based TKI-free regimen in the first line setting and plans to secure casdatifan as the backbone therapy in ccRCC; the timing and achievement of milestones, including the completion of enrollment in PEAK-1, the initiation of the next Phase 3 study for casdatifan, and the advancement of AB102 into the clinic; the progression into the clinic of additional molecules from Arcus’s inflammation and immunology programs; the timing of future data presentations; and expectations regarding the decline in its operating expenses, year-end cash balance and its anticipated cash runway. 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: Arcus’s ability to manage the breadth and pace of its development plans for casdatifan; the unexpected emergence of adverse events or other undesirable side effects with casdatifan; difficulties or delays in initiating, enrolling and completing clinical trials, including due to regulatory review, site activation, patient identification or enrollment, or manufacturing and supply constraints of investigational or standard-of-care products for such clinical trials; interim data not being guarantees of future data or replicated in other studies evaluating casdatifan, including the Phase 3 PEAK-1 study; adverse data from toxicology studies that affect Arcus’s ability to advance development candidates from its immunology and inflammation programs; the risk that the preclinical profiles of Arcus’s development candidates may not translate in clinical trials; changes in the competitive landscape for Arcus’s programs; the inherent uncertainty associated with pharmaceutical product development and clinical trials; and risks associated with Arcus’s ability to accurately forecast financial results and changes in Arcus’s operating plans. 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. ARCUS BIOSCIENCES, INC. Consolidated Statements of Operations (unaudited) (In millions, except per share amounts) Three Months Ended
March 31, 2026 2025 Revenues: License and development services $ 12 $ 20 Other collaboration 5 8 Total revenues 17 28 Operating expenses: Research and development 122 122 General and administrative 29 28 Total operating expenses 151 150 Loss from operations (134 ) (122 ) Non-operating income (expense): Interest and other income, net 9 11 Interest expense (3 ) (1 ) Total non-operating income, net 6 10 Loss before income taxes (128 ) (112 ) Income tax expense — — Net loss $ (128 ) $ (112 ) Net loss per share: Basic and diluted $ (1.02 ) $ (1.14 ) Shares used to compute net loss per share: Basic and diluted 125.4 98.4 Selected Consolidated Balance Sheet Data (unaudited) (In millions) March 31,
2026 December 31, 2025 (1) Cash, cash equivalents and marketable securities $ 876 $ 1,010 Total assets 997 1,139 Total liabilities 473 508 Total stockholders’ equity 524 631 (1) Derived from the audited financial statements for the year ended December 31, 2025, included in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 25, 2026. View source version on businesswire.com: https://www.businesswire.com/news/home/20260505861210/en/ Investor & Media Inquiries:
Holli Kolkey
VP of Corporate Affairs
(650) 922-1269
hkolkey@arcusbio.com Maryam Bassiri
Director of Corporate Affairs
(510) 406-8520
mbassiri@arcusbio.com Original: Arcus Biosciences Reports First-Quarter 2026 Financial Results and Provides a Pipeline Update

Arcus Presents New Data for its HIF-2a Inhibitor Casdatifan, Which Showed Progression-Free Survival Beyond One Year in Late-Line Kidney CancerFebruary 23, 2026 5:00 PM
Business Wire

Median progression-free survival (mPFS) was 15.1 months, and the confirmed overall response rate (cORR) increased to 45% for the 100mg QD (once daily) tablet cohort in an updated analysis of the ARC-20 study

In a pooled analysis of all four monotherapy cohorts (n=121), casdatifan data were better on every efficacy measure evaluated relative to published data from studies with the only marketed HIF-2a inhibitor

New biomarker data demonstrated correlation between magnitude and durability of serum erythropoietin (sEPO) suppression by casdatifan and clinical benefit, including cORR and PFS

Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules for patients with cancer and inflammatory and autoimmune diseases, today announced a new analysis of efficacy and biomarker data for casdatifan, a HIF-2a inhibitor with best-in-class potential, in late-line metastatic clear cell renal cell carcinoma (ccRCC) from the Phase 1/1b ARC-20 study. These data will be presented in a poster session on February 28, 2026, at the American Society of Clinical Oncology Genitourinary Cancer Symposium.

“Patients in the 100mg tablet cohort reached 15.1 months of PFS, and 45% had a confirmed response when treated with the same dose and formulation being used in the ongoing Phase 3 study,” said Richard Markus, M.D., Ph.D., chief medical officer at Arcus Biosciences. “With longer follow-up, ORR continued to improve for both the 100mg QD cohort and pooled analysis, increasing meaningfully since the last analysis. Whether evaluating the pooled data or 100mg Phase 3 formulation data, PFS was two or nearly three times longer relative to published data from studies with the only marketed HIF-2a inhibitor in the same patient population.”

ARC-20 is a Phase 1/1b dose-escalation and expansion study that included four monotherapy cohorts (n=121), which evaluated casdatifan in patients with metastatic ccRCC, most of whom had progressed on at least two prior lines of therapy, including both an anti-PD-1 and a VEGFR tyrosine kinase inhibitor (TKI): 50mg twice daily (BID), 50mg QD, 100mg QD (tablet) and 150mg QD. For biomarker analysis, serial serum samples were collected, and associations between maximal sEPO reduction and response to casdatifan were evaluated. These data showed that the magnitude and durability of EPO suppression correlated with clinical benefit, thereby linking pharmacodynamic modulation by casdatifan to clinical efficacy, including ORR and PFS.

“An analysis of data for casdatifan, a next-generation HIF-2a inhibitor, showed the majority of patients reached near-maximal sEPO reduction, and that deep and prolonged suppression was associated with better response and clinical benefit,” said Toni K. Choueiri, M.D., director of the Lank Center for Genitourinary (GU) Oncology at Dana-Farber, the Jerome and Nancy Kohlberg chair and professor of medicine at Harvard Medical School, and lead investigator of ARC-20. “HIF-2a inhibition has emerged as a novel treatment that is changing the treatment paradigm for patients with ccRCC, and the results from ARC-20 are very encouraging. I look forward to working with Arcus to bring this medicine to ccRCC patients as soon as possible.”

At the time of data cut-off (DCO, August 15, 2025), no unexpected safety signals were observed, and casdatifan had an acceptable and manageable safety profile across all doses. Across all four cohorts, no patients discontinued treatment due to anemia, and four patients (3%) discontinued due to hypoxia.

100mg QD Tablet

(Phase 3 dose)

(n=32)

Pooled Analysis

(50mg BID, 50mg QD, 100mg QD, 150mg QD)

(n=127)

Safetya

Any Serious Treatment-Emergent Adverse Events (TEAEs)

31% (10)

31% (39)

Grade ≥3 TEAEs related to casdatifanb

Anemia

25% (8)

41% (52)

Hypoxia

9% (3)

11% (14)

TEAEs resulting in discontinuation

9% (3)

9% (11)

Anemiac

0

0

Hypoxiac

3% (1)

2% (3)

a The safety-evaluable population included all dose-expansion enrolled patients who received any amount of any study treatment.

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

c Prespecified events of interest.

An updated analysis was conducted for efficacy with a DCO of January 30, 2026. The safety profile remained consistent with the August 15, 2025 DCO. Key differences between the August 15, 2025 and January 30, 2026 DCO are as follows:

100mg QD tablet cohort: At 17.9 months of median follow-up, cORR increased to 45% with an mPFS of 15.1 months. An mPFS had not yet been reached, and cORR was 35% at the August 15, 2025 DCO.

Pooled analysis: At 20.8 months of median follow-up, cORR increased to 35%, with three of the four monotherapy cohorts having cORRs greater than 30%, and mPFS was stable at 12.2 months; cORR was 31% at the August 15, 2025 DCO.

100mg QD Tablet

(Phase 3 dose)

(n=31)

Pooled Analysis

(50mg BID, 50mg QD, 100mg QD, 150mg QD)

(n=121)

Efficacya

Median Follow-Up

17.9 months

20.8 months

Median PFS

15.1 months

12.2 months

[95% CI]

[5.7,NE]

[9.4,16.5]

12-month PFS [95% CI]

61% [42,76]

51% [41,60]

6-month PFS [95% CI]

68% [48,81]

63% [54,71]

Confirmed ORR (cORR) [95% CI]

45% (14) [27,64]

35% (42) [26,44]

Confirmed BOR

CR

0

1% (1)

PR

45% (14)

34% (41)

SD

39% (12)

46% (56)

PDb,c

16% (5)

19% (23)

Median Time to Response

2.6 months

2.8 months

Disease Control Rate

84% (26)

81% (98)

[95% CI]

[66,95]

[73,88]

BOR: best overall response; CI: confidence interval; CR: complete response; NE: not estimable; PR: partial response; PD: progressive disease; SD: stable disease

a As of DCO of January 30, 2026; efficacy-evaluable population for this expansion cohort is defined as all eligible participants who received any study treatment and have at least one post-baseline efficacy assessment, or discontinued study treatment due to progressive disease or death.

b PD was defined according to RECIST v1.1 as a ≥ 20% increase in the sum of diameters of target lesions relative to the smallest sum on study (including baseline, if smallest), with an absolute increase of ≥ 5 mm. The appearance of 1 or more new lesions was also considered progression.

c Includes two patients in the 100mg QD tablet cohort, and also included in the pooled analysis, who had clinical progression before the first scan and therefore did not meet criteria for progressive disease per RECIST. PD based on RECIST criteria was 10% (n=3) for the 100mg QD tablet cohort and 17% (n=121).

About Casdatifan (AB521)

Casdatifan is a small-molecule inhibitor of HIF-2a, a master switch that turns on hundreds of genes in response to low oxygen levels. In a majority of people with the most common form of kidney cancer (clear cell renal cell carcinoma), genetic anomalies result in the dysregulation of this master switch and transformation of normal kidney cells into cancerous ones.

Casdatifan was designed to provide deep and durable inhibition of the HIF-2a pathway. Early clinical studies have shown high response rates and a low primary progression rate relative to clinical benchmarks, warranting further investigation in late-stage studies. Casdatifan, which is administered in pill form once daily, has a safety profile that allows it to be investigated in combination with other treatments.

Currently, fewer than one in four patients with late-line ccRCC respond to monotherapy treatment with a HIF-2a inhibitor, and a next-generation option, like casdatifan, may help more patients achieve benefit from HIF-2a-inhibitor treatment.

Casdatifan is an investigational molecule. Approval from any regulatory authority for its use has not been received, and its safety and efficacy have not been established. Taiho has development and commercial rights in Japan and other countries in Asia, excluding China. Arcus Biosciences holds full rights to casdatifan everywhere else globally.

About RCC

According to the American Cancer Society, kidney cancer is among the top 10 most commonly diagnosed forms of cancer among both men and women in the U.S., and an estimated 80,450 Americans will be diagnosed with kidney cancer in 2026. Clear cell RCC is the most common type of kidney cancer in adults. If detected in its early stages, the five-year survival rate for kidney cancer is high; for patients with advanced or late-stage metastatic kidney cancer, however, the five-year survival rate is only 19%. For metastatic kidney cancer, targeted drug therapies are one of the main treatment options.

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.

Important Information Regarding Data Comparisons

This press release includes comparisons between data from our Phase 1/1b ARC-20 trial and published data from separate trials that are not head-to-head studies. Cross-trial comparisons should be interpreted with caution due to differences in study populations, sample sizes, inclusion and exclusion criteria, trial design, and other factors that may limit direct comparability.

Important Information Regarding 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, casdatifan as a next generation HIF-2a inhibitor. 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 a guarantee of future data and may not be 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; 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260223145191/en/
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

Director, Corporate Affairs

(510) 406-8520

mbassiri@arcusbio.com

Original: Arcus Presents New Data for its HIF-2a Inhibitor Casdatifan, Which Showed Progression-Free Survival Beyond One Year in Late-Line Kidney Cancer