Arcus Biosciences, Inc. (NYSE:RCUS) on Friday announced the discontinuation of the Phase 3 STAR-221 study, being conducted in partnership with Gilead Sciences, Inc. (NASDAQ:GILD) , due to futility. • Arcus Biosciences stock is among today’s weakest performers. Why is RCUS stock dropping?The decision is based on the recommendation from the Independent Data Monitoring Committee (IDMC) following its review of data from an event-driven, pre-specified interim analysis of overall survival (OS).STAR-221 evaluated ...

Financial Data and Key Metrics Changes - The company has over $1 billion in cash, which provides substantial capital for executing its strategic plans and covering readouts for all ongoing programs [15] - The annual sales run rate for Merck's belzutifan, a comparable product, is approximately $700 million, indicating a significant market opportunity for the company's casdatifan [5][6] Business Line Data and Key Metrics Changes - Casdatifan is highlighted as the primary value driver for the company, with data showing it has a better profile than belzutifan across multiple endpoints, including primary progression rates and progression-free survival (PFS) [9][10] - The company has three programs in Phase III, including the anti-TIGIT program, which is expected to read out in 2026, and a CD73 inhibitor study that was fully enrolled ahead of schedule [12][13][15] Market Data and Key Metrics Changes - The renal cancer market is a significant focus, with the company targeting a large patient population that has previously been treated with immune-oncology therapies [19][22] - The competitive landscape in renal cancer is less intense compared to other oncology markets, which may facilitate quicker enrollment and data readouts for the company's studies [22] Company Strategy and Development Direction - The company aims to leverage its complete ownership of casdatifan to create strategic optionality across its portfolio, positioning it as a foundational asset for future growth [6] - The strategy includes a fast-to-market approach for casdatifan, with a focus on combining it with established therapies like CABO to enhance treatment efficacy [19][23] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the differentiation of casdatifan from competitors, citing robust clinical data and a favorable safety profile [11][12] - The company anticipates rapid enrollment in its studies due to the favorable design and the lack of competing studies in the renal cancer space [22][23] Other Important Information - The company is actively exploring additional immunology programs and has plans to enter the clinic with a new HIF-2alpha inhibitor next year [15] - The company is also considering various combinations for its frontline studies, including potential collaborations with AstraZeneca [40][41] Q&A Session Summary Question: What are the key differentiators for casdatifan compared to belzutifan? - Management highlighted that casdatifan shows better primary progression rates, response rates, and PFS compared to belzutifan, with significant clinical data supporting these claims [9][10] Question: What is the expected timeline for the ongoing studies? - The goal is to complete enrollment for the CAS-CABO study by the end of next year, with primary completion expected by April 2028 [24][25] Question: How does the company plan to manage safety profiles in combination therapies? - The safety profile of casdatifan combined with CABO appears favorable, with high dose intensity maintained throughout treatment, which is a positive indicator for patient management [37][38] Question: What is the significance of the STAR-221 trial? - STAR-221 is expected to read out in 2026 and is positioned as a pivotal study for the company's anti-TIGIT program, with promising early data suggesting a potential for improved overall survival [90][91] Question: How does the company view the competitive landscape for its products? - Management noted that the renal cancer space is less competitive, which may facilitate quicker enrollment and data readouts, providing a strategic advantage [22]

Arcus Biosciences (NYSE:RCUS) FY Conference December 02, 2025 04:40 PM ET Company ParticipantsJennifer Jarrett - COOTerry Rosen - CEOConference Call ParticipantsNone - AnalystNoneAll right. Well, good afternoon, everybody. Welcome. Thank you so much to Arcus Management for joining us. We've got Terry and Jen here with us. I can't wait to go through all the exciting data and all the updates coming soon. But let's start with a minute or two from you. What are you excited about heading into 2026? Where are the ...

Core Insights - Arcus Biosciences Inc. has announced positive results for its kidney cancer drug casdatifan, which is part of billionaire Steve Cohen's investment picks [1][2]. Group 1: Clinical Trial Results - The Phase 1/1b study of casdatifan, a HIF-2a inhibitor, showed positive results across all efficacy measures, with a median progression-free survival (PFS) of 12.2 months in trials involving 121 patients [2]. - The drug demonstrated a confirmed overall response rate (ORR) of 31% when analyzing pooled data from patients treated with casdatifan monotherapy, which is significantly longer than existing data for the only marketed HIF-2a inhibitor and for tyrosine kinase inhibitors (TKIs) in similar patient populations [3]. Group 2: Safety Profile - Casdatifan exhibited an acceptable safety profile, with anemia and hypoxia being the primary adverse events; only 9% of patients discontinued treatment due to these adverse events [2]. Group 3: Company Overview - Arcus Biosciences Inc. is a clinical-stage biopharmaceutical company focused on discovering and developing novel combination therapies for cancer, utilizing both small molecules and antibodies to meet unmet medical needs [4].

Core Insights - Taiho Pharmaceutical Co., Ltd. has exercised its option to develop and commercialize casdatifan, a small molecule HIF-2 inhibitor, in Japan and certain other Asian territories, excluding mainland China [1] Group 1 - The option exercise is based on a 2017 agreement between Taiho and Arcus Biosciences [1]

Core Insights - Arcus Biosciences Inc. announced new monotherapy data for casdatifan in late-line metastatic clear cell renal cell carcinoma (ccRCC) [1] - The drug trials are part of a Phase 1/1b study with four cohorts, showing promising results in terms of overall response rate and progression-free survival [1][2] Efficacy Data - In the 100mg tablet cohort, casdatifan demonstrated a 35% confirmed overall response rate (ORR) with median progression-free survival (mPFS) not yet reached after one year of follow-up [2] - Pooled data from 121 patients indicated a confirmed ORR of 31% and a median PFS of 12.2 months, which is significantly longer than existing treatments [3] Safety Profile - At the data cut-off on August 15, 2025, 81% of patients experienced disease control, with 74% of confirmed responders remaining on treatment [4] - No unexpected safety signals were reported, and the safety profile of casdatifan was deemed acceptable and manageable across all doses [4][5] Market Reaction - Following the announcement, Arcus Biosciences shares rose by 7.87% to $14.40, trading within a 52-week range of $6.50 to $18.98 [5]

Summary of Arcus Biosciences FY Conference Call (September 10, 2025) Company Overview - **Company**: Arcus Biosciences (NYSE: RCUS) - **Industry**: Biotechnology, specifically focused on oncology Strategic Priorities - **Execution of Phase III Programs**: The primary focus is on the global Phase III program for casdatifan, a HIF2 inhibitor, with two studies targeting earlier line settings in renal cell carcinoma (RCC) [2][3] - **Funding and Partnerships**: The company has received significant funding from partners like Gilead Sciences, AstraZeneca, and Taiho Pharmaceutical, allowing them to operationalize only two of five Phase III studies [2] - **Capital Preservation**: The company has over $900 million in cash and is focused on conserving capital by pausing less strategic initiatives [8] Pipeline Highlights - **Casdatifan**: - Targeting RCC with a market opportunity of approximately $5 billion in G7 countries [4] - Data from 90 patients showed clear differentiation from Merck's belzutifan on efficacy measures [3] - Upcoming data presentation on 120 patients expected to provide more follow-up information [4][12] - **Domvanalimab**: - An Fc-silent anti-TIGIT antibody being evaluated in combination with anti-PD-1 and chemotherapy in first-line gastric cancer [5] - Expected readout in 2026 from a 1,000-patient study [5] - **Quemliclustat**: - A small molecule CD73 inhibitor in combination with chemotherapy for first-line pancreatic cancer, with a 600-patient study expected to provide data soon [5] Competitive Landscape - **FDA Interactions**: The company reports steady communication with the FDA, with no significant impact from recent changes in agency policies [10] - **Benchmarking Against Belzutifan**: - Casdatifan has shown a confirmed overall response rate (ORR) of 33%, significantly higher than belzutifan's 18%-22% [14] - Progression-free survival (PFS) for casdatifan was reported at 9.7 months, compared to belzutifan's 5.6 months [15][16] Market Opportunities - **Gastric Cancer**: The market opportunity for TAP greater than 5 is estimated at $3 billion in G7 countries [70] - **Lung Cancer**: The lung cancer market is projected to exceed $10 billion, with potential for multiple players [77] Collaboration and Partnerships - **Collaboration with AstraZeneca**: AstraZeneca is operationalizing the Evolve study, which is capital-efficient for Arcus, allowing them to retain all economic rights [48] Intellectual Property - **IP Duration**: Casdatifan has a patent life extending to 2041, providing a long-term competitive advantage [51] Conclusion - Arcus Biosciences is strategically positioned with a robust pipeline and significant market opportunities in oncology, particularly with casdatifan and its combination therapies. The company is focused on execution, capital preservation, and leveraging partnerships to enhance its operational efficiency and market presence.

Pipeline and Programs - Arcus Biosciences has $927 million in cash, cash equivalents, and marketable securities as of June 30, 2025, funding operations through initial pivotal readouts for domvanalimab, quemliclustat, and casdatifan, including PEAK-1[10] - Casdatifan plus cabozantinib showed a confirmed ORR of 46% in patients who reached a minimum of 12 weeks of follow-up in IO-experienced ccRCC[16] - In first-line PDAC, a Phase 1 study showed a median overall survival (mOS) of 157 months (n=122) for patients treated with a quemliclustat-based regimen, exceeding historical benchmarks for chemotherapy alone (85 – 117 months)[108] - The company is targeting substantial market opportunities with three late-stage programs: Post-IO ccRCC (~$2B), IO-naive ccRCC (~$3B), 1L Gastric/GEJ/EAC (~$3B), 1L NSCLC (~$10B), and 1L PDAC (>$4B)[12] Casdatifan (HIF-2α Inhibitor) - Casdatifan plus cabozantinib in IO-experienced ccRCC demonstrated a high confirmed overall response rate (cORR) of 46% with a low rate of primary progression of 4%[29] - Casdatifan monotherapy in 2L+ ccRCC showed a confirmed ORR ranging from 21% to 33% across three cohorts, with median progression-free survival (PFS) of 97 months in the 50mg BID cohort[53] - Casdatifan achieves similar PD effect (EPO suppression) at only 20mg, one-fifth the "going forward" dose of 100mg[21] Domvanalimab (Anti-TIGIT mAb) - In the Phase 2 EDGE-Gastric study, patients with TAP ≥ 5% had a median PFS of 138 months, while those with TAP < 5% had a median PFS of 113 months[82] - In 1L PD-L1 High NSCLC, domvanalimab + zimberelimab showed a median PFS of 93 months compared to 54 months for zimberelimab alone, with a HR of 067[90] - In 1L PD-L1 High NSCLC, domvanalimab + zimberelimab showed a HR of 064 for overall survival (OS) compared to zimberelimab alone[90] Partnerships - Arcus retains co-promotion rights and profit share in the US, with high-teens to low-20's royalties on ex-US sales[19] - Taiho has development/commercial rights in Japan and the rest of Asia (ex-China), with up to $275 million in milestones per program and high single-digit to mid-teens royalties[19]

Casdatifan (Cas) & Cabozantinib (Cabo) Combination Therapy - The combination of Cas and Cabo shows a confirmed Overall Response Rate (ORR) of 46% in patients eligible for a minimum of 12 weeks follow-up [32] - In the Cas + Cabo cohort, 98% of patients experienced any treatment-related Adverse Events (AEs) [46] - The median duration of follow-up for patients on Cas 100mg QD + Cabo 60mg QD was 37 months [43] Casdatifan Development and Market Opportunity - Arcus Biosciences has $1 billion in cash to fund pivotal readouts for Domvanalimab (dom), Quemliclustat (quemli), and Casdatifan (cas), including the PEAK-1 trial [12] - Belzutifan prescriptions have grown 154% from December 2023 to April 2025 [74] - Belzutifan achieved LTM sales of >$560 million in the US, with run rate sales based on April Rx's at $720 million+ [75] Clinical Trial and Future Development - PEAK-1, a Phase 3 study, is expected to initiate imminently for post-IO ccRCC, randomizing patients to either 100mg Casdatifan + Cabozantinib or Placebo + Cabozantinib in a 2:1 ratio with approximately 700 patients [67, 68] - Arcus is targeting a $3 billion market opportunity in IO-naive metastatic ccRCC with Casdatifan + Volrustomig (volru) [85] - Arcus is also targeting a $2 billion market in post-IO metastatic ccRCC with Casdatifan + Cabozantinib [85]

COMBINING TO CURE ® Arcus is at the forefront of designing combination therapies, with best-in-class potential, in the relentless pursuit of cures for cancer. May 6, 2025 CORPORATE PRESENTATION Notice of Trademark: The Arcus name and logo are the property of Arcus. All other trademarks used herein are the property of their respective owners and are used for reference purposes only. Such use should not be construed as an endorsement of Arcus. Forward-Looking Statements/Safe Harbor Forward Looking Statements ...