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Arcus Biosciences(RCUS) - 2024 Q3 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The company reported GAAP revenue of 48millionforQ32024,anincreasefrom48 million for Q3 2024, an increase from 39 million in Q2 2024, primarily driven by collaborations with Gilead and Taiho [35] - Cash position improved to 1.1billionattheendofQ32024,upfrom1.1 billion at the end of Q3 2024, up from 1 billion at the end of Q2 2024, bolstered by a 100 million collaboration continuation payment from Gilead [34] - R&D expenses for Q3 2024 were 123 million, compared to 115millioninQ22024,withexpectationsofmodestincreasesinQ42024[36]BusinessLineDataandKeyMetricsChangesThecompanyisfocusedonlaunchingthelatestagedevelopmentprogramforitsHIF2alphainhibitor,Casdatifan,withpromisinginitialdatafromtheARC20study[6][12]TheARC20studyshoweda34115 million in Q2 2024, with expectations of modest increases in Q4 2024 [36] Business Line Data and Key Metrics Changes - The company is focused on launching the late-stage development program for its HIF-2 alpha inhibitor, Casdatifan, with promising initial data from the ARC-20 study [6][12] - The ARC-20 study showed a 34% overall response rate (ORR) and a 25% confirmed ORR for the 100 mg cohort, indicating strong efficacy compared to belzutifan [8][11] - Domvanalimab, the company's anti-TIGIT antibody, demonstrated a median progression-free survival (PFS) of 11.5 months in the ARC-10 study, exceeding benchmarks for anti-PD-1 monotherapy [15][31] Market Data and Key Metrics Changes - The company is targeting a 2 billion plus market opportunity in the G7 countries for the PEAK-1 study, which will enroll approximately 700 patients [24][25] - The potential market for Casdatifan in the IO naive setting is estimated to exceed 3billionacrosstheG7countries[26]TheSTAR221studyinfirstlinegastriccancerhasthepotentialtobefirsttomarketwithanantiTIGITantibody,representinga3 billion across the G7 countries [26] - The STAR-221 study in first-line gastric cancer has the potential to be first to market with an anti-TIGIT antibody, representing a 3 billion plus opportunity [20] Company Strategy and Development Direction - The company aims to differentiate Casdatifan from belzutifan by demonstrating superior efficacy and safety profiles, particularly in heavily pre-treated patient populations [6][10] - The strategic focus includes advancing multiple Phase 3 trials for Domvanalimab and expanding the development program for Casdatifan into other RCC subpopulations [21][27] - The company is also exploring collaborations to enhance its clinical development plans, particularly with AstraZeneca for combination therapies [25][70] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the durability of responses observed in the ARC-20 study, anticipating further improvements in ORR and PFS as more data becomes available [9][12] - The company is well-funded with a cash runway into mid-2027, allowing for continued investment in clinical trials and development programs [22][37] - Management highlighted the importance of the upcoming data presentations and the initiation of Phase 3 studies as key milestones for the company [39] Other Important Information - The company plans to present additional data from the ARC-20 study throughout 2025, including more mature ORR and median PFS [12] - The safety data from the combination cohorts have been consistent with the profiles of the individual drugs, indicating a favorable safety profile for Casdatifan [12][32] - The company has received inbound interest from other potential partners, indicating strong market interest in its programs [63] Q&A Session Summary Question: Interest in Casdatifan and Gilead's opt-in potential - Management confirmed alignment with Gilead on the data needed for the qualifying data package, with a decision expected late this year or early next year [42] Question: Preclinical work with Volru and Casdatifan - No preclinical work was done; the collaboration was based on well-defined profiles of the two molecules [43] Question: Development plans for Etrumadenant - Management is excited about the data set and is working through next steps with Gilead [44] Question: Next steps in IO naive renal cell cancer setting - Management agreed with AstraZeneca to not comment further until the study is listed on clinicaltrials.gov [46] Question: Strategy for managing treatment exposure in trials - Management emphasized starting with a full dose of Cabo and leveraging existing safety data to manage toxicities effectively [72]