Arcus Biosciences Q2 2025 slides: advancing late-stage oncology pipeline with $1B cash

Introduction & Market Context

Arcus Biosciences (NASDAQ:NYSE:RCUS) presented its corporate strategy and pipeline updates on May 6, 2025, highlighting its focus on developing combination therapies for cancer treatment. The clinical-stage biopharmaceutical company reported a strong financial position with $1 billion in cash, providing runway through multiple pivotal data readouts for its three main clinical programs.

The company’s stock closed at $8.12 on May 6, down 9.17% from the previous close of $8.94, reflecting ongoing market volatility in the biotech sector despite the company’s pipeline progress. In after-hours trading, shares recovered slightly, up 0.37% to $8.15.

Pipeline Overview

Arcus is advancing three late-stage programs targeting significant market opportunities across multiple cancer indications. The company’s pipeline focuses on novel mechanisms with potential best-in-class profiles.

As shown in the following comprehensive pipeline overview, Arcus has positioned its assets to address substantial market opportunities:

The company’s late-stage programs target markets with combined potential exceeding $24 billion. Casdatifan (HIF-2α inhibitor) targets renal cell carcinoma, domvanalimab (anti-TIGIT) addresses gastric cancer and non-small cell lung cancer, and quemliclustat (CD73 inhibitor) is being developed for pancreatic cancer.

The following chart details these programs and their respective market opportunities:

Casdatifan Highlights

Arcus’s lead program, casdatifan, is a small molecule HIF-2α inhibitor positioned as potentially best-in-class for clear cell renal cell carcinoma (ccRCC). The Phase 3 PEAK-1 trial is expected to initiate in Q2 2025, evaluating casdatifan in combination with cabozantinib in patients who have progressed after immunotherapy.

The ARC-20 study results demonstrate casdatifan’s compelling efficacy profile compared to competitive therapies:

Across three dosing cohorts, casdatifan showed objective response rates (ORR) of 25-33%, compared to high teens to low 20% for belzutifan ( Merck (NSE:PROR)’s HIF-2α inhibitor). The 100mg QD tablet formulation, selected for Phase 3 development, demonstrated a 33% ORR with a median time to response of 1.6 months.

Detailed efficacy measures across different dosing regimens show consistent activity:

Progression-free survival data further supports casdatifan’s potential advantage, with the 50mg BID cohort achieving 9.7 months median PFS compared to 5.6 months for belzutifan in the LITESPARK-005 study:

The Phase 3 PEAK-1 trial design aims to confirm these benefits in a larger patient population:

Domvanalimab Program

Domvanalimab, Arcus’s anti-TIGIT antibody, is advancing in three Phase 3 trials across gastric cancer and non-small cell lung cancer. The company positions it as the most clinically advanced Fc-silent anti-TIGIT antibody in development.

The following illustration explains domvanalimab’s mechanism of action:

In the Phase 2 EDGE-Gastric study, the combination of domvanalimab, zimberelimab (anti-PD-1), and chemotherapy demonstrated a median progression-free survival of 12.9 months in the intent-to-treat population, comparing favorably to benchmarks from other trials (6.9-7.7 months).

The Phase 3 STAR-221 trial in gastric cancer is expected to report data in 2026, with potential to establish a new standard of care in this indication.

Strategic Partnerships

Arcus has established strategic partnerships with major pharmaceutical companies to accelerate development and share costs. These collaborations provide validation for Arcus’s platform while preserving significant economics.

Key partnerships include:

1. Gilead (NASDAQ:GILD): Co-promotion rights and profit share in the US, royalties on ex-US sales, and opt-in rights to most programs

2. Taiho Pharma: Development and commercial rights in Japan and Asia (excluding China), milestone payments, and royalties

3. AstraZeneca (NASDAQ:AZN): Collaboration on the PACIFIC-8 trial combining domvanalimab with durvalumab

Forward-Looking Statements

Arcus outlined several key data milestones expected in 2025:

1. Early 2025: Updated data from ARC-20 for casdatifan across multiple dosing regimens

2. June 2025: ARC-20 casdatifan + cabozantinib combination data at ASCO

3. Fall 2025: EDGE-Gastric Phase 2 overall survival data and more mature ARC-20 data

4. 2026 (event-driven): STAR-221 Phase 3 data for domvanalimab in gastric cancer

The company’s $1 billion cash position is expected to fund operations through these pivotal readouts, supporting potential commercialization planning if the data is positive.

Competitive Positioning

In the renal cell carcinoma market, Arcus aims to position casdatifan as the HIF-2α inhibitor of choice. The current US market is fragmented, with various combinations of immunotherapy and tyrosine kinase inhibitors dominating first-line treatment.

The company highlights casdatifan’s potential advantage in dosing convenience, offering a single 100mg daily tablet compared to competitors requiring multiple pills:

This simplified dosing approach could provide a meaningful advantage for patients on long-term therapy, potentially improving compliance and quality of life.

Conclusion

Arcus Biosciences’ corporate presentation demonstrates the company’s progress in advancing its oncology pipeline, with three programs in Phase 3 development targeting substantial market opportunities. The promising efficacy data for casdatifan in renal cell carcinoma, if confirmed in the upcoming PEAK-1 trial, could position the company for significant growth.

While the stock has faced pressure in recent trading, the company’s strong cash position and strategic partnerships provide runway through multiple potential value-creating catalysts over the next 12-24 months. Investors will be watching closely for the upcoming data presentations, particularly the casdatifan combination data at ASCO in June 2025.

Full presentation:

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