Summary of Arcus Biosciences Investor Event - October 2025 Company Overview - **Company**: Arcus Biosciences - **Focus**: Development of innovative cancer therapies, particularly in renal cell carcinoma (RCC) and immunology - **Key Programs**: Castadafen (HIF2 inhibitor), domvanalimab (anti-TIGIT), quemliclustat (CD73 inhibitor) - **Financial Position**: Over $900 million in funding to support late-stage programs and clinical trials [7][8][14] Key Points on Castadafen - **Priority Program**: Castadafen is the highest priority program due to its scientific, clinical, and commercial validation [3][4] - **Market Potential**: The clear cell RCC market opportunity is estimated at approximately $5 billion, with additional potential in other cancers leading to a total market exceeding $10 billion [15][18] - **Clinical Data**: - Castadafen shows approximately twice the progression-free survival (PFS) compared to belzutifan, with a 50% lower rate of primary progression [17][43] - Confirmed overall response rate (ORR) for castadafen is 35%, compared to 22% for belzutifan [32][43] - Median PFS for castadafen is projected to exceed 12 months, with 60% of patients remaining progression-free at 12 months [40][41] - **Safety Profile**: Castadafen has a comparable safety profile to belzutifan, with serious adverse events (SAEs) at 31% and treatment-related SAEs at 6% [43][44] Other Programs - **Domvanalimab**: Focused on upper GI cancers, with an oral presentation at ESMO expected to provide overall survival data [5][6] - **Quemliclustat**: CD73 inhibitor showing unprecedented overall survival of 16.4 months in combination with gemcitabine/nab-paclitaxel [6][14] Clinical Trials and Collaborations - **PEAK-1 Study**: Ongoing phase 3 study for castadafen in frontline clear cell RCC, with strong enrollment expected due to investigator enthusiasm [12][14] - **Collaboration with AstraZeneca**: Cost-sharing arrangement while maintaining 100% commercial rights to castadafen [13][14] - **Taiho Collaboration**: Potential decision from Taiho regarding participation in the castadafen program [13] Market Competition - **Competitive Landscape**: Competing against major players like Merck and Roche, with a focus on addressing significant medical needs in large markets [14][15] - **Strategic Positioning**: Arcus aims to leverage its well-funded status and strong data to capture market share in the competitive landscape of RCC treatments [14][15] Insights from Key Opinion Leaders - **Dr. Raina McKay**: Emphasized the need for improved treatment options in RCC, highlighting the limitations of current therapies like belzutifan [48][52] - **Patient Journey**: Discussed the typical RCC patient journey and the importance of long-term treatment strategies [49][50] Conclusion - **Future Outlook**: Arcus Biosciences is well-positioned to capitalize on its innovative therapies, particularly castadafen, with strong clinical data and a robust financial foundation to support ongoing and future studies [7][8][15]

Arcus Biosciences Investor Event 2025 October 6, 2025 Agenda | TOPIC | | PRESENTER(S) | TIME (ET) | | --- | --- | --- | --- | | Overview of Arcus | | Dr. Terry Rosen | 10:00-10:10 | | Overview of Casdatifan | | Dr. Terry Rosen | 10:10-10:20 | | New Casdatifan Monotherapy Data | | Dr. Richard Markus | 10:20-10:35 | | Treatment Paradigm in ccRCC | | Dr. Rana McKay | 10:35-10:55 | | | Q&A | | 10:55-11:15 | | Role of HIF-2α in ccRCC and Casdatifan Biomarker Data | | Dr. Juan Jaen | 11:15-11:25 | | Panel Convers ...

Group 1 - Rongchang Biopharma's "Taitasip" is proposed for priority review by CDE for treating adult patients with primary IgA nephropathy, showing significant reduction in proteinuria levels [1] - "Taitasip" has already been approved for three indications in China, including myasthenia gravis, rheumatoid arthritis, and systemic lupus erythematosus, with a recent application for Sjögren's syndrome also accepted [1] Group 2 - Baiyunshan and Guangzhou Pharmaceutical Phase II Fund signed a strategic investment agreement to acquire over 144 million shares of Nanjing Pharmaceutical, making it the second-largest shareholder with an 11.04% stake [2] - This strategic investment aims to enhance market competitiveness through resource integration and synergy, potentially impacting Nanjing Pharmaceutical's governance structure and market performance [2] Group 3 - Pian Zai Huang's Chief Financial Officer Yang Haipeng resigned due to work adjustments, with Deputy General Manager He Wei temporarily taking over the CFO duties [3] - The long-term brand value and market position of Pian Zai Huang remain strong, and if the management transition is smooth, the impact on the company's long-term development may be limited [3] Group 4 - Former Chief Technology Officer of Kailai Ying, Hu Xinhui, has joined Hengrui Medicine as Vice President and Chief Technology Officer, indicating a strategic move to strengthen R&D capabilities [4] - Hu Xinhui's appointment is expected to bring new opportunities for Hengrui Medicine's R&D system upgrades, technological breakthroughs, and international development [4] Group 5 - The former Chairman of Guangzhou Pharmaceutical Group, Li Chuyuan, has been reported for violations of discipline and law, leading to his expulsion from the party and public office [5] - This incident highlights governance and internal oversight issues within Guangzhou Pharmaceutical Group, which may affect investor trust and subsequently impact its stock performance and market reputation [5]

Group 1 - The company is focusing on strategic priorities as it heads into 2026, with an emphasis on pipeline development [2] - Key executives from the company, including the COO and CMO, are present to discuss the company's direction and initiatives [1] - The discussion aims to provide insights into the company's strategic focus and operational goals moving forward [2]

Group 1 - The company is focusing on strategic priorities as it heads into 2026, with an emphasis on pipeline development [2] - Key executives from the company, including the COO and CMO, are present to discuss the company's direction and initiatives [1] - The discussion aims to provide insights into the company's strategic focus and operational goals moving forward [2]

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.

Summary of Arcus Biosciences FY Conference Call Company Overview - **Company**: Arcus Biosciences (NYSE:RCUS) - **Key Personnel**: Jennifer Jarrett (COO), Richard Marcus (CCO), Peter Eaves (CFO) [1] Pipeline Programs and Progress - Arcus has three different programs and five Phase 3 studies, supported by financing from partners like Gilead, AstraZeneca, and Taiho [3] - The primary focus is on **castatinopathy**, a next-generation HIF2 inhibitor, which has shown promising data in multiple medical meetings [3][4] - Initial data for castatinopathy monotherapy showed an overall response rate (ORR) of 31% and a median progression-free survival (PFS) of 9.7 months, outperforming Merck's belzutifan, which had a 22% ORR and 5.6-month PFS [10][20] Market Opportunity - The market for castatinopathy in the G7 markets is estimated to be at least **$2 billion** for second-line treatment and **$3 billion** for first-line treatment [5][33] - The overall renal cell carcinoma (RCC) market is projected to grow from **$10 billion** to **$13 billion** in the coming years, driven by the introduction of HIF2 inhibitors [33] Study Designs and Comparisons - The **PEAK1 Phase 3 trial** is designed to evaluate castatinopathy plus cabozantinib against cabozantinib alone, with PFS as the primary endpoint [12][13] - Arcus believes that their study design is superior to Merck's LIGHTSPARK-11 trial due to the use of cabozantinib as the control arm and focusing solely on PFS [16] Efficacy and Safety - The combination of castatinopathy and cabozantinib has shown a **46% confirmed response rate** in early data, with minimal overlapping toxicities [19][20] - The safety profile of the combination is favorable, with fatigue being the only significant overlapping toxicity observed [19] Collaboration with AstraZeneca - Arcus is collaborating with AstraZeneca on a Phase 1b/3 study evaluating castatinopathy with AstraZeneca's anti-PD-1/CTLA-4 bispecific antibody, volrue [27][30] - AstraZeneca is operationalizing the study and covering 50% of the costs, making it a resource-efficient partnership [30] Future Data and Expectations - Additional monotherapy data is expected to reaffirm previous findings, with a focus on PFS metrics [25][26] - Data from the Phase 1b portion of the AstraZeneca collaboration is anticipated in the second half of next year [31] Competitive Landscape - The HIF2 inhibitor market is currently a two-horse race between Arcus's castatinopathy and Merck's belzutifan, contrasting with other cancer markets that have multiple competitors [33]

Core Insights - Arcus Biosciences, Inc. is a clinical-stage biopharmaceutical company focused on developing differentiated molecules and combination therapies for cancer patients [1] Company Actions - The Compensation Committee of the Company's Board of Directors granted options to purchase a total of 19,300 shares of common stock to three new employees [1] - The exercise price per share for these options is set at $12.19, which reflects the closing price on September 8, 2025 [1]

Group 1 - The Citi Biopharma Back To School Summit is being held, featuring discussions on recent developments in the biotech sector [1] - Arcus Biosciences is presenting, with key executives including the CEO, COO, and Head of Investor Relations participating [2] - The CEO of Arcus Biosciences highlighted the positive outcomes from the recent ASCO event and mentioned upcoming catalysts related to their product, cas [3]

Summary of Arcus Biosciences Conference Call - September 03, 2025 Company Overview - **Company**: Arcus Biosciences (RCUS) - **Focus**: Development of innovative cancer therapies, particularly in the area of HIF-2 alpha inhibitors Key Points and Arguments Product Pipeline and Clinical Trials - **Casdatafan**: - Positioned as a best-in-class HIF-2 alpha inhibitor, with compelling data from 120 patients indicating superior efficacy compared to Merck's belzutafan [6][17] - Total addressable market estimated at $10 billion [7] - Phase 3 studies initiated, including a combination with cabozantinib (cabo) and a collaboration with AstraZeneca for frontline settings [8][10] - Expected rapid enrollment due to investigator enthusiasm [7][11] - **Domzim**: - An anti-TIGIT, anti-PD-1 combination therapy, with data to be presented at ESMO [9][10] - **Quemly**: - A CD73 inhibitor in pancreatic cancer, fully enrolled ahead of schedule, with results expected in the next 12-18 months [12][97] Competitive Landscape - **Comparison with Merck's Belzutafan**: - Casdatafan shows a lower rate of primary progression (15% vs. 35% for belzutafan) and better overall response rates (over 30% vs. just over 20%) [17][18] - Arcus believes their development strategy is superior, focusing on combining with cabo, which is more widely used and easier to manage than Merck's lenvatinib [22][24] Strategic Advantages - **Development Strategy**: - Arcus employs a cleaner statistical analysis plan with a single primary endpoint of progression-free survival (PFS) [30] - Two-to-one randomization in trials to enhance patient enrollment [32] - **Collaboration with AstraZeneca**: - Cost-sharing arrangement for a phase 1b/3 study combining Casdatafan with AstraZeneca's bispecific anti-PD-1/CTLA-4 [40][41] Upcoming Data and Events - **Investor Event**: - Scheduled for October 6, 2025, to present updated data on Casdatafan and other therapies [8] - **Data Readouts**: - Continuous flow of data expected from various studies, including OS data from the Edge Gastric study and the phase 3 study for upper GI cancers [10][66] Market Positioning - **TKI-Sparing Regimen**: - Arcus aims to shift the use of TKIs to later lines of therapy, enhancing patient quality of life by avoiding early toxicities associated with TKIs [49] Other Important Insights - **Safety Profile**: - Casdatafan is expected to have minimal overlapping toxicity with other treatments, which could make it a backbone agent in clear cell renal cell carcinoma (CCRCC) [60] - **Regulatory Landscape**: - No competing phase 3 studies currently exist for Casdatafan, positioning Arcus favorably in the market [35] Conclusion - Arcus Biosciences is in a transformative phase with multiple late-stage clinical trials and a strong competitive position against Merck's belzutafan. The company is focused on delivering innovative therapies with a favorable safety profile and robust efficacy data, aiming to capture significant market share in the oncology space.