[Risk Factor Summary](index=3&type=section&id=RISK%20FACTOR%20SUMMARY) [Risk Factor Summary](index=3&type=section&id=RISK%20FACTOR%20SUMMARY) This section provides a high-level overview of the key risks and uncertainties for Arcus Biosciences, covering financial, development, collaboration, intellectual property, and operational risks - The company has a history of operating losses, has never generated revenue from product sales, and anticipates continued significant losses, potentially requiring additional funding[12](index=12&type=chunk) - Significant risks exist in the drug development process, including potential failure to obtain regulatory approval, delays in clinical trials, and the possibility of serious adverse events or undesirable side effects from investigational products[12](index=12&type=chunk) - The company is heavily dependent on its collaboration with Gilead Sciences for the research, development, and commercialization of its products, and the success of this collaboration is critical[12](index=12&type=chunk) - Arcus faces risks related to intellectual property, including the ability to obtain and maintain sufficient protection for its products and the potential for costly infringement lawsuits[16](index=16&type=chunk) - The company faces substantial competition and is vulnerable to failures or security breaches of its internal and third-party IT systems[16](index=16&type=chunk) [PART I. FINANCIAL INFORMATION](index=5&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements for the three and six months ended June 30, 2025, including the Statement of Operations, Balance Sheet, and Cash Flow Statement [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For Q2 2025, Arcus reported total revenues of **$160 million**, a substantial increase from Q2 2024, leading to a net income of **$0 million** compared to a net loss of **$93 million** in the prior-year period Consolidated Statements of Operations Highlights (in millions, except per share data) | Metric | Q2 2025 | Q2 2024 | 6 Months 2025 | 6 Months 2024 | | :--- | :--- | :--- | :--- | :--- | | **Total Revenues** | **$160** | **$39** | **$188** | **$184** | | License and development services | $152 | $28 | $172 | $163 | | Other collaboration revenue | $8 | $11 | $16 | $21 | | **Total Operating Expenses** | **$168** | **$145** | **$318** | **$306** | | Research and development | $139 | $115 | $261 | $224 | | General and administrative | $29 | $30 | $57 | $62 | | **Net Income (Loss)** | **$0** | **$(93)** | **$(112)** | **$(97)** | | **Diluted EPS** | **$0.00** | **$(1.02)** | **$(1.09)** | **$(1.09)** | [Condensed Consolidated Balance Sheets](index=8&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, total assets were **$1,075 million**, with cash, cash equivalents, and marketable securities totaling **$927 million**, and total stockholders' equity increasing to **$549 million** Key Balance Sheet Items (in millions) | Metric | June 30, 2025 | Dec 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $248 | $150 | | Marketable securities (Current & Long-term) | $679 | $842 | | **Total Assets** | **$1,075** | **$1,150** | | Total current liabilities | $210 | $226 | | Long-term debt | $97 | $48 | | **Total Liabilities** | **$526** | **$665** | | **Total Stockholders' Equity** | **$549** | **$485** | [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the first six months of 2025, net cash used in operating activities was **$265 million**, while investing activities provided **$169 million** and financing activities provided **$194 million**, resulting in a net increase in cash of **$98 million** Cash Flow Summary for Six Months Ended June 30 (in millions) | Cash Flow Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(265) | $(96) | | Net cash provided by (used in) investing activities | $169 | $(106) | | Net cash provided by financing activities | $194 | $231 | | **Net increase in cash, cash equivalents and restricted cash** | **$98** | **$29** | [Notes to Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail significant accounting policies and events, including a **$143 million** cumulative revenue catch-up from a Gilead collaboration modification and details on financing activities - As of June 30, 2025, the company had **$927 million** in cash, cash equivalents, and marketable securities, which management believes is sufficient to fund planned operations for at least the next twelve months[34](index=34&type=chunk) - In June 2025, Gilead terminated its rights to the etrumadenant program, treated as a contract modification, leading to a cumulative catch-up to revenue of **$143 million** during Q2 2025[81](index=81&type=chunk) - In Q1 2025, the company sold **13.6 million shares** of common stock in an underwritten offering for gross proceeds of approximately **$150 million**[116](index=116&type=chunk) - The company drew an additional **$50 million** in Q2 2025 under its loan agreement with Hercules, bringing the total long-term debt balance to **$97 million**[111](index=111&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=26&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial results, clinical portfolio, and strategic updates, highlighting a **$143 million** revenue catch-up, increased R&D expenses, positive casdatifan data, and sufficient capital for future operations [Overview and Clinical Portfolio](index=26&type=section&id=Overview%20and%20Clinical%20Portfolio) Arcus is a clinical-stage biopharmaceutical company focused on cancer therapies, with its most advanced molecule, an anti-TIGIT antibody, in multiple Phase 3 studies, and a key collaboration with Gilead - The company's most advanced molecule is an anti-TIGIT antibody in multiple Phase 3 registrational studies for lung and GI cancers[131](index=131&type=chunk) - In Q2 2025, Gilead returned its license to the adenosine receptor antagonist program (etrumadenant), and the HIF-2α program (casdatifan) is no longer subject to Gilead's option[132](index=132&type=chunk) [Significant Developments](index=28&type=section&id=Significant%20Developments) Key recent developments include initial positive data for the casdatifan program, Orphan Drug Designation for quemliclustat, and the strategic decision to pause future development of etrumadenant - Initial data from the ARC-20 study of casdatifan plus cabozantinib showed a **46% confirmed overall response rate** in patients with metastatic cancer, supporting the initiation of two new studies[143](index=143&type=chunk) - In July 2025, quemliclustat received Orphan Drug Designation from the FDA for the treatment of pancreatic cancer[138](index=138&type=chunk) - The company decided to pause future development of etrumadenant, and in June 2025, Gilead returned its license to the program[139](index=139&type=chunk) [Results of Operations](index=30&type=section&id=Results%20of%20Operations) Total revenues for Q2 2025 were **$160 million**, a **310% increase** from Q2 2024, primarily due to a **$143 million** cumulative revenue catch-up, while R&D expenses increased **21%** to **$139 million** - The increase in total revenues for Q2 2025 was primarily driven by a **$143 million** cumulative catch-up from license and development services revenue related to Gilead's return of its license to the etrumadenant program[152](index=152&type=chunk) Research and Development Expenses by Category (in millions) | Category | Q2 2025 | Q2 2024 | Change | 6 Months 2025 | 6 Months 2024 | Change | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Late-stage development programs | $74 | $64 | 16% | $129 | $127 | 2% | | Early-stage R&D and preclinical programs | $38 | $33 | 15% | $80 | $58 | 38% | | Compensation and personnel costs | $45 | $45 | 0% | $94 | $90 | 4% | | Partnership reimbursements | $(33) | $(40) | (18)% | $(71) | $(77) | (8)% | | **Total R&D** | **$139** | **$115** | **21%** | **$261** | **$224** | **17%** | - Management expects R&D expenses to decline commencing in the fourth quarter of 2025 as costs related to the domvanalimab Phase 3 development program decrease significantly[158](index=158&type=chunk) [Liquidity and Capital Resources](index=33&type=section&id=Liquidity%20and%20Capital%20Resources) The company ended Q2 2025 with **$927 million** in cash, cash equivalents, and marketable securities, deemed sufficient to fund operations for at least the next twelve months and through key clinical readouts - The company believes its cash, cash equivalents, and marketable securities as of June 30, 2025, will be sufficient to fund planned operations for at least twelve months and through initial pivotal read-outs for domvanalimab, quemliclustat, and casdatifan[166](index=166&type=chunk) - In February 2025, the company raised approximately **$150 million** in gross proceeds from an underwritten offering of common stock[171](index=171&type=chunk) - In Q2 2025, the company drew an additional **$50 million** from its **$250 million** term loan facility with Hercules[170](index=170&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=37&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's market risks, primarily from potential losses due to changes in interest rates and foreign currency exchange rates, have not materially changed from its prior annual report - The company's primary market risks arise from potential changes in interest rates and foreign currency exchange rates, and these risks have not changed materially since the last annual report[186](index=186&type=chunk) [Item 4. Controls and Procedures](index=37&type=section&id=Item%204.%20Controls%20and%20Procedures) As of June 30, 2025, management concluded that the company's disclosure controls and procedures were effective, with no material changes in internal control over financial reporting during the quarter - Based on an evaluation as of the end of the period, the Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective at the reasonable assurance level[189](index=189&type=chunk) - There were no changes in the company's internal control over financial reporting during the quarter ended June 30, 2025, that have materially affected, or are reasonably likely to materially affect, internal controls[190](index=190&type=chunk) [PART II. OTHER INFORMATION](index=38&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=38&type=section&id=Item%201.%20Legal%20Proceedings) The company reports that it is not currently a party to any material legal proceedings - As of the filing date, the company is not a party to any material legal proceedings[193](index=193&type=chunk) [Item 1A. Risk Factors](index=38&type=section&id=Item%201A.%20Risk%20Factors) This section details significant risks, including limited operating history, financial position, product development uncertainties, reliance on third parties, intellectual property vulnerabilities, and substantial competition - The company has a history of operating losses, an accumulated deficit of **$1.2 billion** as of June 30, 2025, and expects to incur significant losses for the foreseeable future[195](index=195&type=chunk) - Clinical drug development is a lengthy, expensive, and uncertain process, and the company's investigational products may not be effective or may have side effects that preclude marketing approval[200](index=200&type=chunk)[207](index=207&type=chunk) - The business is highly dependent on its collaboration with Gilead; conflicts, termination of the agreement, or failure by Gilead to commercialize products could adversely affect the company[239](index=239&type=chunk) - The company relies on third-party manufacturers, including WuXi Biologics in China for its key products zimberelimab and domvanalimab, creating risks related to supply chain, quality control, and geopolitical tensions[247](index=247&type=chunk)[311](index=311&type=chunk) - The company faces substantial competition in the immunotherapy market, and competitors may develop safer, more effective, or less expensive products more quickly[298](index=298&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=72&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports no unregistered sales of equity securities or use of proceeds for the period - None[366](index=366&type=chunk) [Item 5. Other Information](index=72&type=section&id=Item%205.%20Other%20Information) This section discloses the adoption of Rule 10b5-1 trading arrangements by two of the company's officers during the second quarter of 2025 Rule 10b5-1 Trading Arrangements Adopted in Q2 2025 | Name and Title | Action | Date | Total Shares to be Sold | Expiration Date | | :--- | :--- | :--- | :--- | :--- | | Alex Azoy, Chief Accounting Officer | Adoption | June 6, 2025 | 28,022 | June 4, 2026 | | Jennifer Jarrett, Chief Operating Officer | Adoption | June 30, 2025 | 100,583 | April 10, 2026 | [Item 6. Exhibits](index=73&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including the certifications of the Principal Executive Officer and Principal Financial Officer - The report includes a list of filed exhibits, such as officer certifications (31.1, 31.2, 32.1, 32.2) and XBRL data files[372](index=372&type=chunk)

Exhibit 99.1 HAYWARD, Calif. – (BUSINESS WIRE) – Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for patients with cancer, today reported financial results for the second quarter ended June 30, 2025, and provided a pipeline update on its clinical-stage investigational molecules across multiple common cancers. "We have now presented data from over 125 patients treated with casdatifan monotherapy o ...

Pipeline and Programs - Arcus Biosciences has $927 million in cash, cash equivalents, and marketable securities as of June 30, 2025, funding operations through initial pivotal readouts for domvanalimab, quemliclustat, and casdatifan, including PEAK-1[10] - Casdatifan plus cabozantinib showed a confirmed ORR of 46% in patients who reached a minimum of 12 weeks of follow-up in IO-experienced ccRCC[16] - In first-line PDAC, a Phase 1 study showed a median overall survival (mOS) of 157 months (n=122) for patients treated with a quemliclustat-based regimen, exceeding historical benchmarks for chemotherapy alone (85 – 117 months)[108] - The company is targeting substantial market opportunities with three late-stage programs: Post-IO ccRCC (~$2B), IO-naive ccRCC (~$3B), 1L Gastric/GEJ/EAC (~$3B), 1L NSCLC (~$10B), and 1L PDAC (>$4B)[12] Casdatifan (HIF-2α Inhibitor) - Casdatifan plus cabozantinib in IO-experienced ccRCC demonstrated a high confirmed overall response rate (cORR) of 46% with a low rate of primary progression of 4%[29] - Casdatifan monotherapy in 2L+ ccRCC showed a confirmed ORR ranging from 21% to 33% across three cohorts, with median progression-free survival (PFS) of 97 months in the 50mg BID cohort[53] - Casdatifan achieves similar PD effect (EPO suppression) at only 20mg, one-fifth the "going forward" dose of 100mg[21] Domvanalimab (Anti-TIGIT mAb) - In the Phase 2 EDGE-Gastric study, patients with TAP ≥ 5% had a median PFS of 138 months, while those with TAP < 5% had a median PFS of 113 months[82] - In 1L PD-L1 High NSCLC, domvanalimab + zimberelimab showed a median PFS of 93 months compared to 54 months for zimberelimab alone, with a HR of 067[90] - In 1L PD-L1 High NSCLC, domvanalimab + zimberelimab showed a HR of 064 for overall survival (OS) compared to zimberelimab alone[90] Partnerships - Arcus retains co-promotion rights and profit share in the US, with high-teens to low-20's royalties on ex-US sales[19] - Taiho has development/commercial rights in Japan and the rest of Asia (ex-China), with up to $275 million in milestones per program and high single-digit to mid-teens royalties[19]

Casdatifan (HIF-2α) Program - Casdatifan 100mg QD tablet showed a 33% confirmed ORR (Overall Response Rate) with short follow-up[15,19] - Casdatifan 100mg QD tablet showed a 15% primary progressive disease (PD) rate[15] - Casdatifan 50mg BID cohort showed a median Progression Free Survival (mPFS) of 9.7 months[15,25] - Casdatifan 50mg QD cohort showed mPFS not reached with 12 months follow-up[15,25] - The PEAK-1 Phase 3 study for Casdatifan is on track to initiate in Q2 2025[33] Domvanalimab (Anti-TIGIT mAb) Program - Domvanalimab plus Zimberelimab in 1L Gastric Cancer showed ~13 months mPFS vs 7-8 months for benchmark data[11] - In 1L PD-L1 High NSCLC, Domvanalimab + Zimberelimab vs Zimberelimab showed OS Hazard Ratio of 0.64[11,58] - EDGE-Gastric data showed 13.8 months median PFS in TAP ≥5% and 11.3 months median PFS in TAP < 5%[47] - STAR-221 is a Phase 3 study evaluating Domvanalimab + Zimberelimab + Chemo in 1L Gastric/GEJ/EAC, with data expected in 2026[51,52] CD73-Adenosine Axis Programs - Quemli ± Zim + G/nP in 1L Metastatic PDAC showed 15.7 months mOS vs 9.8 months for Synthetic Control Arm, representing a 37% reduction in risk of death[70]

Summary of the Conference Call Company and Industry - **Company**: Arcus Biosciences - **Industry**: Oncology, specifically focusing on clear cell renal cell carcinoma (CCRCC) Key Points and Arguments 1. **Clinical Trial Data Announcement**: Arcus announced data from the cascadafan plus cabozantinib combination cohort of the Phase 1b ARC20 clinical trial in CCRCC, presented at the ASCO conference on June 1, 2025 [2][4] 2. **Efficacy of Combination Therapy**: The initial data from the CAS plus CABO cohort showed a confirmed overall response rate (ORR) of 46%, which is significantly higher than the benchmarks for cabozantinib monotherapy (20-40%) and belzutafan plus cabozantinib (31%) [8][21] 3. **Durability of Responses**: All responders in the CAS plus CABO cohort remain on treatment, indicating durable responses even with a median follow-up of only five months [9][21] 4. **Safety Profile**: The adverse event (AE) profile for the combination therapy is consistent with expectations for each agent alone, with only 5% of patients discontinuing due to AEs, and no patients discontinuing both drugs [10][28] 5. **Strategic Positioning**: Arcus owns the rights to cascadafan, providing significant strategic flexibility and optionality in its development and commercialization [6] 6. **Phase III Study Initiation**: The company is preparing to initiate its first Phase III study (PEEK-one) for cascadafan, expecting rapid enrollment due to strong investigator enthusiasm [5][31] 7. **Market Opportunity**: The market for HIF2 alpha inhibitors in CCRCC is growing, with belzutafan sales reaching over $560 million in the last twelve months. Arcus believes cascadafan could capture a significant share of this market due to its superior profile [34][36] 8. **Combination with Other Therapies**: The potential for cascadafan to be combined with various standard-of-care agents in RCC is highlighted, particularly due to its lack of overlapping toxicities with other treatments [38][39] 9. **Future Development Plans**: Arcus plans to expand its development program for cascadafan, targeting both first-line and second-line settings in CCRCC, with the goal of establishing it as the preferred HIF2 alpha inhibitor [32][41] Other Important Content 1. **Patient Demographics**: The majority of patients in the trial had received prior immunotherapy (IO), with 83% having one prior line of therapy, indicating a contemporary treatment paradigm [20] 2. **Regulatory Filings**: The data presented will support the company's IND filing for the initiation of the PEEK-one study [19] 3. **Collaboration with AstraZeneca**: The EVOLVE RCC-two study, sponsored by AstraZeneca, is designed to assess the safety and efficacy of a TKI-free combination for RCC patients, enhancing resource efficiency [16][60] 4. **Long-term Follow-up**: The company expects to present more mature results from ongoing cohorts over the next 18 months, including ORR and progression-free survival (PFS) data [29][30] This summary encapsulates the critical insights from the conference call, focusing on the company's clinical advancements, market positioning, and future strategies in the oncology sector.

Casdatifan (Cas) & Cabozantinib (Cabo) Combination Therapy - The combination of Cas and Cabo shows a confirmed Overall Response Rate (ORR) of 46% in patients eligible for a minimum of 12 weeks follow-up [32] - In the Cas + Cabo cohort, 98% of patients experienced any treatment-related Adverse Events (AEs) [46] - The median duration of follow-up for patients on Cas 100mg QD + Cabo 60mg QD was 37 months [43] Casdatifan Development and Market Opportunity - Arcus Biosciences has $1 billion in cash to fund pivotal readouts for Domvanalimab (dom), Quemliclustat (quemli), and Casdatifan (cas), including the PEAK-1 trial [12] - Belzutifan prescriptions have grown 154% from December 2023 to April 2025 [74] - Belzutifan achieved LTM sales of >$560 million in the US, with run rate sales based on April Rx's at $720 million+ [75] Clinical Trial and Future Development - PEAK-1, a Phase 3 study, is expected to initiate imminently for post-IO ccRCC, randomizing patients to either 100mg Casdatifan + Cabozantinib or Placebo + Cabozantinib in a 2:1 ratio with approximately 700 patients [67, 68] - Arcus is targeting a $3 billion market opportunity in IO-naive metastatic ccRCC with Casdatifan + Volrustomig (volru) [85] - Arcus is also targeting a $2 billion market in post-IO metastatic ccRCC with Casdatifan + Cabozantinib [85]

Company Performance - Arcus Biosciences reported a quarterly loss of $1.14 per share, which was worse than the Zacks Consensus Estimate of a loss of $1.02, and compared to a loss of $0.05 per share a year ago, indicating a significant decline in performance [1] - The company posted revenues of $28 million for the quarter ended March 2025, missing the Zacks Consensus Estimate by 14.24%, and a sharp decline from year-ago revenues of $145 million [2] - Over the last four quarters, Arcus Biosciences has surpassed consensus EPS estimates two times and topped consensus revenue estimates three times [2] Stock Performance - Arcus Biosciences shares have lost about 40% since the beginning of the year, significantly underperforming the S&P 500, which declined by only 3.9% [3] - The current consensus EPS estimate for the coming quarter is -$1.08 on revenues of $30.7 million, and for the current fiscal year, it is -$4.13 on revenues of $123.83 million [7] Industry Outlook - The Medical - Biomedical and Genetics industry, to which Arcus Biosciences belongs, is currently ranked in the top 31% of over 250 Zacks industries, suggesting a favorable industry outlook [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact the stock's performance [5]

Financial Data and Key Metrics Changes - The company reported cash of $1 billion at the end of Q1 2025, an increase from $992 million at the end of 2024, bolstered by a $150 million equity financing completed in February 2025 [34] - GAAP revenue for Q1 2025 was $8 million, down from $36 million in Q4 2024, primarily driven by collaboration with Gilead [35] - The company expects to recognize GAAP revenue of $75 million to $90 million for the full year 2025 [35] Business Line Data and Key Metrics Changes - The late-stage portfolio is focused on casdadefan, with ongoing studies expected to generate significant data over the next two years [6][11] - The Fc silent anti-TIGIT antibody, domvanilumab, is on track for its first Phase III study readout in 2026, while the PRISM-one trial for the small molecule CD73 inhibitor is expected to be fully enrolled by the end of 2025 [14][17] Market Data and Key Metrics Changes - The addressable patient population for casdadefan in the IO naive setting is approximately 13,000 in the U.S. and 20,000 in other major markets, with a combined market opportunity estimated at $5 billion [31][32] - TKI-based regimens dominate the clear cell RCC market, holding approximately 65% share in the first line and 75% in the second line setting [32] Company Strategy and Development Direction - The company aims to bring casdadefan to market as quickly as possible, focusing on its advantages over existing therapies [6][11] - There is a strategic collaboration with AstraZeneca to develop a TKI-free combination option for first-line RCC, which is expected to enhance the market position of casdadefan [12][96] - The long-term vision includes developing casdadefan in earlier lines of therapy to displace TKIs, driven by a better safety profile and efficacy [11][12] Management's Comments on Operating Environment and Future Outlook - Management acknowledges the tumultuous macro environment but emphasizes a commitment to efficient execution and resource allocation [5][6] - The company expects a steady flow of data for casdadefan over the next couple of years, reinforcing its competitive advantages [6][10] Other Important Information - The company has a strong balance sheet with $1 billion in cash and investments, allowing it to fund operations through pivotal readouts [17][34] - The company is prioritizing its late-stage programs while maintaining a sustainable pipeline with minimal investment in early-stage programs [43] Q&A Session Summary Question: Can you elaborate on pipeline reprioritization and the adenosine inhibitor program? - Management confirmed that while there is a path forward for the adenosine modulator, current plans do not include moving forward with it at this time [41][42] Question: What should be expected in the ASCO presentation regarding the CAS data? - The ASCO presentation will feature more recent data than the abstract, including safety and efficacy data from approximately 40 patients [44][45] Question: Are there plans to ramp up investment in the TIGIT program? - Management expressed confidence in the current investments and highlighted ongoing discussions for potential future studies based on positive Phase II readouts [52] Question: What is the expected efficacy benchmark for CAS in the second line? - Management indicated that they are looking for meaningful reductions in tumor size and a safety profile that encourages investment in CAS for earlier lines of therapy [55][57] Question: What is the timeline for the PEEK-one study? - Management stated that while it is too early to provide specific timelines, they expect the study to enroll quickly and anticipate a readout that could narrow the gap with competing studies [66][68]

Financial Data and Key Metrics Changes - The company reported cash of $1 billion at the end of Q1 2025, an increase from $992 million at the end of 2024, bolstered by a $150 million equity financing completed in February 2025 [34][36] - GAAP revenue for Q1 2025 was $8 million, down from $36 million in Q4 2024, primarily driven by collaboration with Gilead [35] - The company expects to recognize GAAP revenue of $75 million to $90 million for the full year 2025 [35] Business Line Data and Key Metrics Changes - The late-stage portfolio is focused on the casdadefan program, which is the top priority, with ongoing data generation expected to reinforce its advantages over competitors [4][5] - The Fc silent anti-TIGIT antibody, domvanilumab, is advancing towards its first Phase III study readout, expected in 2026 [14] - The PRISM-one trial of QEMLi, a small molecule CD73 inhibitor, is enrolling rapidly and is anticipated to be fully enrolled by the end of 2025 [16] Market Data and Key Metrics Changes - The addressable patient population for the IO naive setting is approximately 13,000 in the U.S. and 20,000 in other major markets, with a combined market opportunity estimated at $5 billion [30][31] - TKI-based regimens dominate the clear cell RCC market, holding approximately 65% share in the first line and 75% in the second line settings [31] Company Strategy and Development Direction - The company aims to develop casdadefan in TKI-free regimens, targeting earlier lines of RCC treatment to improve patient quality of life [11][12] - Collaborations with AstraZeneca are focused on combining casdadefan with their anti-PD-1/CTLA-4 bispecific antibody for first-line RCC, marking a strategic move towards TKI-free options [12][96] - The company is prioritizing late-stage programs while maintaining a sustainable pipeline with minimal investment in early-stage programs [43] Management's Comments on Operating Environment and Future Outlook - Management remains focused on execution amidst a tumultuous macro environment, ensuring resource deployment reflects ongoing assessments of priorities [4][5] - The company anticipates a steady flow of data for casdadefan over the next couple of years, reinforcing its competitive position [5][10] - Management expressed confidence in the ability to fund operations through pivotal readouts, with a strong balance sheet supporting ongoing development [34][36] Other Important Information - The company is exploring additional cohorts in the ARC20 study to evaluate casdadefan in various settings, including TKI-free regimens [13][19] - The competitive landscape for anti-TIGIT antibodies has shifted, with the company and AstraZeneca's candidates dominating the Phase III landscape [15] Q&A Session Summary Question: Can you elaborate on pipeline reprioritization and the adenosine inhibitor program? - Management confirmed that while there is a path forward for the adenosine modulator, current plans do not include moving forward with it at this time, focusing instead on late-stage programs like casdadefan [39][41] Question: What should be expected in the ASCO presentation versus the abstract? - Management indicated that the ASCO presentation will feature more recent data, including safety and efficacy for a population of about 40 patients, with compelling results anticipated [44][46] Question: What is the plan for the Peak One study and its primary endpoint? - Management stated that it is too early to provide specific timelines for the Peak One study's PFS primary endpoint, but they expect rapid enrollment and are focused on collecting OS data as a key secondary endpoint [66][68] Question: Will the company consider commercialization partnerships post-Peak One? - Management expressed intent to commercialize casdadefan independently, with potential consideration for a partner in Europe, emphasizing confidence in their capabilities [108]

COMBINING TO CURE ® Arcus is at the forefront of designing combination therapies, with best-in-class potential, in the relentless pursuit of cures for cancer. May 6, 2025 CORPORATE PRESENTATION Notice of Trademark: The Arcus name and logo are the property of Arcus. All other trademarks used herein are the property of their respective owners and are used for reference purposes only. Such use should not be construed as an endorsement of Arcus. Forward-Looking Statements/Safe Harbor Forward Looking Statements ...