Financial Data and Key Metrics Changes - The company reported GAAP revenue of $33 million for Q4 2025, an increase from $26 million in Q3 2025, primarily driven by collaboration with Gilead [35] - Cash at the end of Q4 was $1 billion, up from $841 million at the end of Q3, bolstered by a $288 million financing in November [35][36] - R&D expenses decreased to $121 million in Q4 from $141 million in Q3, while G&A expenses slightly decreased from $27 million to $26 million [35] Business Line Data and Key Metrics Changes - The confirmed overall response rate (ORR) for the 100 mg cohort of casdatifan increased from 35% to 45%, with a median progression-free survival (PFS) of 15.1 months [16][18] - The pooled analysis ORR improved from 31% to 35%, significantly higher than belzutifan's observed rates [16][18] Market Data and Key Metrics Changes - The renal cell carcinoma (RCC) market is projected to grow from over $10 billion annually today to $13 billion by 2030, with casdatifan targeting a peak sales opportunity of $5 billion in first and second-line RCC settings [24][26] - The company aims to capture a substantial share of the IO-experienced setting, which includes approximately 21,000 patients in major markets, nearly double the third-line patient population where belzutifan is approved [26] Company Strategy and Development Direction - The company is focused on establishing casdatifan as the best-in-class HIF-2 inhibitor and the new standard of care for clear cell RCC, with a fast-to-market strategy for its Phase III study, PEAK-1 [4][8] - A TKI-free regimen is being developed for frontline therapy, which is expected to improve patient quality of life and treatment outcomes [10][11] - The immunology portfolio is also being expanded, with two programs expected to enter the clinic within the next 12 months [14][30] Management's Comments on Operating Environment and Future Outlook - Management emphasized the transformative potential of 2026 for the company, with multiple data presentations and advancements in clinical programs expected [4][39] - The company is confident in its ability to fund operations until at least the second half of 2028, with a significant decrease in operating expenses anticipated for 2026 [37][38] Other Important Information - The company is leveraging its ARC-20 study to drive development strategy for casdatifan, with a focus on demonstrating its best-in-class profile [12][22] - The upcoming ASCO GU presentation is expected to provide critical data that will reinforce the differentiation of casdatifan from belzutifan [7][39] Q&A Session Summary Question: What are the benchmarks for IO therapies as the company moves away from TKI-based regimens? - Management highlighted Ipi-Nivo as a key benchmark, noting its primary progression rate of 20%-25% and PFS of around 12 months, with the goal to demonstrate meaningful improvement with casdatifan [44][46] Question: What is the status of the volrustomig plus casdatifan study? - The study was paused but continues to provide valuable data, with no primary progression observed since dose adjustments [50][51] Question: How does the company view the upcoming LITESPARK-011 data from Merck? - Management expressed optimism that positive data from Merck would validate the field and drive enrollment for PEAK-1, with confidence in outperforming Merck's combination [65][66] Question: What is the impact of potential discontinuation of STAR-121 based on futility analysis? - Management indicated minimal operational impact as the study is fully enrolled, with a decrease in expenses expected in the latter stages of the trial [81][82]

Summary of Arcus Biosciences FY Conference Call Company Overview - **Company**: Arcus Biosciences (NYSE:RCUS) - **Founded**: Approximately 10 years ago with a focus on small molecule drug development, particularly in oncology and immunology [2][3] Key Points on Oncology Programs - **Current Portfolio**: Two late-stage oncology programs and an emerging immunology portfolio [2] - **Financial Position**: Well-capitalized with $1 billion in cash, expected to last until the second half of 2028, covering initial phase three readouts and early immunology program proof of concept [3] Casdatifan Program - **Target**: HIF-2, validated by Merck's Belzudafan, which has a run rate of $800 million annually in late-line settings [5] - **Clinical Data**: - Casdatifan shows a median progression-free survival (PFS) of over 12 months compared to 5.6 months for Belzudafan in late-line settings [9] - Casdatifan demonstrates deeper and more durable suppression of erythropoietin production than Belzudafan [8] - **Market Opportunity**: Estimated at $5 billion, with potential to become the standard of care in kidney cancer [7][22] - **Development Strategy**: - PEAK-1 study combines casdatifan with TKI cabozantinib, expected to enroll quickly [11] - Plans to establish a TKI-sparing regimen in the front line, addressing the high rate of primary progression associated with current treatments [12][35] Quemliclustat Program - **Focus**: Small molecule CD73 inhibitor for front-line pancreatic cancer, showing a median overall survival (OS) of approximately 16 months compared to 9-11 months for standard care [17] - **Market Potential**: Estimated at over $4 billion [18] Immunology Programs - **Focus**: Targeting validated settings with high commercial potential using small molecules [19] - **MRGPRX2 Antagonist**: Aiming to treat atopic skin diseases, expected to enter the clinic in 2026 [19] - **Selective TNF Receptor 1 Inhibitor**: Anticipated to enter the clinic by late 2026 or early 2027, addressing limitations of current TNF antibodies [20][22] Strategic Insights - **Partnerships**: Shift from leveraging partnerships for capital to focusing on clinical collaborations that enhance internal programs [29][30] - **Market Recognition**: The market for casdatifan is underappreciated, with potential for long-term patient treatment leading to significant revenue [45] Financial and Operational Outlook - **Cash Needs**: Recent disappointing results from the STAR-221 trial have extended cash runway into the second half of 2028 [41] - **Execution Focus**: Emphasis on executing the development strategy and maintaining a diverse portfolio to mitigate binary risks associated with drug development [25][46] Conclusion - **Differentiation**: Arcus Biosciences stands out due to its ability to run late-stage trials while maintaining a robust discovery pipeline, positioning itself competitively against larger biotech firms [46][47]

Arcus Biosciences J.P. Morgan Healthcare Conference 2026 Oncology and Immunology Portfolio January 14, 2026 Forward-looking Statements/Safe Harbor Forward-Looking Statements Safe Harbor: This presentation contains forward-looking statements about Arcus Biosciences, Inc. ("we," "Arcus" or the "Company") made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements in this presentation that are not historical facts are forward-looking statements, including ...