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 ...

Summary of Key Points from the Conference Call Industry Overview - **Industry**: US Biopharmaceuticals - **Performance**: Biopharma ended 2025 positively with NBI up 32% and DRG up 21%, outperforming SPX at 17% [1] - **Outlook for 2026**: Optimism exists despite macro concerns like inflation and tariffs, with easing drug pricing worries, increased M&A activity, new product cycles, and modest expectations positioning the sector favorably [1] Core Insights and Arguments - **Valuation**: Biotech/Pharma P/E multiples are around 19x, which is lower compared to Financials at 18x and Utilities at 20x, indicating potential undervaluation [1] - **Catalysts**: Companies like Insmed (+152%), BridgeBio (+179%), and Travere (+119%) have shown strong performance driven by value-driving catalysts [1] Company-Specific Highlights Insmed - **Performance**: Insmed was a top performer in 2025, driven by Brinsupri's launch and TPIP's phase 2 results [2] - **2026 Outlook**: Continued upside is expected as Brinsupri's uptake alleviates skepticism over the $5B NCFB opportunity [2] BridgeBio - **Focus for 2026**: The debate will center around Attruby, with positive channel checks suggesting potential for accelerated sales [2] - **Key Data**: Anticipation for PROPEL3 readout in January, which could significantly impact the stock [10] Travere - **Performance**: Outperformance in 2025 attributed to commercial success in IgAN [3] - **Approval Outlook**: Filspari's potential approval for FSGS is a major debate, with FDA signals indicating a favorable outlook [9] Cytokinetics - **Market Entry**: Myqorzo's approval for oHCM is expected to face challenges in market execution against established competitors [15][40] - **Upcoming Data**: ACACIA readout in 2Q26 is crucial for assessing the drug's competitive position [19] Tyra - **Expansion**: Tyra is expanding dabogratinib's development into LG-UTUC, which could offer greater regulatory flexibility and market opportunity [43] - **Market Potential**: Management believes an oral option could be a game changer in a relatively underserved market [43] Acumen - **Pipeline Development**: Acumen's EBD program is expected to provide optionality, with initial non-clinical data anticipated early in 2026 [13] - **Key Event**: ALTITUDE-AD is a defining event for Acumen, with expectations for significant data to outperform competitors [33] Additional Important Insights - **M&A Activity**: The biopharma sector is seeing increased M&A activity as companies prepare for patent expirations [1] - **Regulatory Environment**: The FDA's involvement in various drug approvals and feedback mechanisms is crucial for shaping market expectations [9][10] - **Investor Sentiment**: There remains a cautious sentiment among investors, particularly regarding the approval of new drugs and their market uptake [9][19] This summary encapsulates the key points from the conference call, highlighting the overall industry outlook, company-specific developments, and critical upcoming events that could influence market dynamics in the biopharmaceutical sector.

Core Insights - Arcus Biosciences has a promising oncology pipeline, supported by positive clinical data and a strong balance sheet, positioning it as a potential high-upside growth stock [1][2] - The company faced a significant setback with the cancellation of its Phase 3 STAR-221 trial due to inefficiency, which has raised questions about its investment case [2][6] - Despite the challenges, Arcus is focusing its resources on its key programs, particularly casdatifan, which shows potential as a leading treatment for kidney cancer [7] Company Overview - Arcus Biosciences is valued at $2.7 billion and operates as a clinical-stage biopharmaceutical company, developing treatments for cancer and autoimmune diseases [4] - The company does not currently sell any approved medicines, with its main oncology programs including casdatifan for clear cell kidney cancer and quemliclustat for pancreatic cancer [4] STAR-221 Trial Details - The STAR-221 trial was a large Phase 3 study involving over 1,000 participants across approximately 30 countries, aimed at improving survival rates in advanced upper gastrointestinal cancers [5] - The trial was discontinued after an interim review indicated no overall survival improvement compared to standard therapy [6] Future Focus - Following the discontinuation of STAR-221, Arcus will concentrate its capital and R&D efforts on casdatifan and its immuno-oncology portfolio [7] - Positive results from the Phase 1/1b ARC-20 study have strengthened the company's belief in casdatifan's potential as a best-in-class medication for kidney cancer [7]

Core Insights - Arcus Biosciences has announced the discontinuation of the Phase 3 STAR-221 study due to futility, following a recommendation from the Independent Data Monitoring Committee after an interim analysis of overall survival [1][2]. Study Discontinuation - The STAR-221 study evaluated the combination of anti-TIGIT antibody domvanalimab and anti-PD-1 antibody zimberelimab with chemotherapy against nivolumab plus chemotherapy for untreated patients with advanced gastric and esophageal cancers [2]. - The interim analysis revealed that the domvanalimab-based combination did not improve overall survival compared to nivolumab plus chemotherapy, with a similar safety profile and no new safety findings [3]. Future Directions - Arcus will focus its R&D efforts on casdatifan, a potential best-in-class HIF-2α inhibitor, which has shown strong single-agent activity in over 120 late-line clear cell renal cell carcinoma (ccRCC) patients in the ARC-20 Phase 1/1b study [5]. - Key milestones for casdatifan include additional analyses in early 2026, more mature combination data by mid-2026, and potential initiation of a Phase 3 trial in late 2026 [6][7]. Oncology Pipeline - Arcus is advancing quemliclustat, a small-molecule CD73 inhibitor, with the Phase 3 PRISM-1 trial in first-line metastatic pancreatic ductal adenocarcinoma having completed enrollment earlier this year, with results expected in 2027 [8]. Immunology and Inflammation Pipeline - The immunology and inflammation portfolio includes several oral small-molecule programs, with two candidates expected to enter clinical trials in the near future [10][11].

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]

Summary of Arcus Biosciences FY Conference Call Company Overview - **Company**: Arcus Biosciences (NYSE: RCUS) - **Focus**: Development of innovative cancer therapies, particularly in the area of HIF-2 inhibitors and anti-TIGIT therapies Key Points 1. Strategic Focus on Casdatifan - Casdatifan is highlighted as a primary focus due to its ownership and strategic optionality - The drug is considered highly de-risked based on internal data and validation from belzutifan, which has a current run rate of $700 million despite being sold in late lines only - Casdatifan shows superior data compared to belzutifan across multiple efficacy measures, including progression-free survival (PFS) which is more than double that of belzutifan [2][3] 2. Upcoming Data and Studies - Anticipation for more data in 2026, particularly regarding front-line strategies and phase 3 studies - STAR-221, a phase 3 study correlating with EDGE-Gastric, is expected to read out in 2026, with 1,050 patients fully enrolled by June 2024 [5][6] - STAR-121, focusing on PD-L1 non-small cell lung cancer, will also be fully enrolled by the end of this year with 1,000 patients [6] 3. Anti-TIGIT Developments - Arcus has demonstrated differentiation between Fc-silent and Fc-enabled anti-TIGIT molecules, with promising data from the EDGE-Gastric study showing overall survival (OS) exceeding two years compared to approximately 13 months for standard treatments [4][5] - The company is optimistic about the STAR-221 results influencing the sentiment around STAR-121 [6] 4. Combination Therapies - Casdatifan is expected to provide meaningful benefits when combined with other therapies, such as cabozantinib (CABL) and anti-PD-1 agents, showing higher overall response rates compared to belzutifan combinations [9][10][11] - The combination of CAST (casdatifan) with CABL has shown a response rate of over 40% compared to 31% for belzutifan plus CABL [11] 5. Tolerability and Patient Management - CABL is favored by clinicians for its better tolerability compared to lenvatinib (Lenva), with lower incidences of common TKI-related adverse events [26][27] - The management of anemia in patients on HIF-2 therapy has been effective, with no discontinuations due to anemia reported in a cohort of 120 patients [18][19] 6. Future Directions - Arcus plans to explore additional combinations, including anti-PD-1 and bispecific therapies, to enhance treatment efficacy [30][31] - The company is focused on TKI-sparing regimens, allowing for better quality of life for patients while reserving TKIs for later stages of treatment [34] 7. Clinical Trials and Data Expectations - More mature data from the CAST plus CABL cohort is expected to be presented next year, with a focus on PFS and durability of response [21][24] - The company is also monitoring the performance of Merck's Lenva and belzutifan combinations for comparative insights [26] 8. Conclusion - Arcus Biosciences is positioned to make significant advancements in cancer treatment through its innovative therapies and strategic focus on casdatifan and anti-TIGIT developments, with several key studies and data releases anticipated in the near future [36]

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]