Group 1 - Jim Cramer recommended buying Uranium Energy Corp (UEC), expressing a positive outlook on nuclear energy [1] - HC Wainwright & Co. analyst Heiko F. Ihle maintained a Buy rating for Uranium Energy and raised the price target from $12.25 to $12.75 [1] - Arcus Biosciences, Inc. (RCUS) was described as a speculative investment by Cramer, advising caution and diversification in investment strategy [2] - Wells Fargo analyst Eva Fortea Verdejo maintained an Overweight rating for Arcus Biosciences but lowered the price target from $26 to $25 [2] Group 2 - Arcus Biosciences shares increased by 4% to close at $10.06 [4] - Uranium Energy shares decreased by 1.1% to close at $10.22 [4]

Group 1 - The article promotes a weekly newsletter focused on stocks in the biotech, pharma, and healthcare industries, highlighting key trends and catalysts that influence market valuations [1] - The newsletter is designed for both novice and experienced biotech investors, offering insights on product sales, forecasts for major pharmaceutical companies, and detailed financial analyses [1] - Edmund Ingham, a biotech consultant with over five years of experience, leads the investing group Haggerston BioHealth and has compiled extensive reports on more than 1,000 companies in the sector [1]

Financial Performance - Arcus Biosciences reported break-even quarterly earnings per share, compared to a Zacks Consensus Estimate of a loss of $1.14, and a loss of $1.02 per share a year ago, indicating an earnings surprise of +100.00% [1] - The company posted revenues of $160 million for the quarter ended June 2025, surpassing the Zacks Consensus Estimate by 593.24%, compared to year-ago revenues of $39 million [2] - Over the last four quarters, Arcus Biosciences has surpassed consensus EPS estimates three times and topped consensus revenue estimates three times [2] Stock Performance - Arcus Biosciences shares have lost about 35.9% since the beginning of the year, while the S&P 500 has gained 7.1% [3] - The current status translates into a Zacks Rank 3 (Hold) for the stock, indicating expected performance in line with the market in the near future [6] Earnings Outlook - The current consensus EPS estimate for the coming quarter is -$1.21 on revenues of $22.96 million, and -$4.59 on revenues of $91.93 million for the current fiscal year [7] - The estimate revisions trend for Arcus Biosciences was mixed ahead of the earnings release, which could change following the recently released earnings report [6] Industry Context - The Medical - Biomedical and Genetics industry, to which Arcus Biosciences belongs, is currently in the bottom 42% of the Zacks industries, indicating potential challenges for stock performance [8] - Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions, suggesting that industry outlook can materially impact stock performance [5][8]

[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)

[Executive Summary](index=1&type=section&id=Executive%20Summary) [Introduction and CEO Statement](index=1&type=section&id=1.1%20Introduction%20and%20CEO%20Statement) Arcus Biosciences announced Q2 2025 financial results and pipeline updates, with the CEO highlighting casdatifan's potential as a best-in-class HIF-2a inhibitor for ccRCC and confirming sufficient funding for key clinical trials - Arcus Biosciences is a clinical-stage global biopharmaceutical company focused on developing differentiated molecules and combination therapies for cancer patients[2](index=2&type=chunk) - CEO Dr. Terry Rosen stated that data from over 125 patients treated with casdatifan monotherapy or in combination with cabozantinib suggest its potential as a **best-in-class HIF-2a inhibitor** for clear cell renal cell carcinoma (ccRCC)[3](index=3&type=chunk) - The company is rapidly advancing casdatifan's development in multiple ccRCC settings, including the global Phase 3 PEAK-1 trial for IO-experienced patients and the Phase 1b/3 eVOLVE-RCC02 trial for first-line metastatic patients[3](index=3&type=chunk) [Pipeline Update](index=1&type=section&id=Pipeline%20Update) [Casdatifan (HIF-2a Inhibitor)](index=1&type=section&id=2.1%20Casdatifan%20(HIF-2a%20inhibitor)) Preliminary ARC-20 study data for casdatifan + cabozantinib in IO-experienced metastatic ccRCC patients showed a **46% confirmed overall response rate (ORR)** with good tolerability, and two pivotal Phase 3 studies (PEAK-1 and eVOLVE-RCC02) have commenced, with more mature data anticipated - Preliminary data from the ARC-20 study of casdatifan + cabozantinib in IO-experienced metastatic ccRCC patients showed that nearly half of patients had a confirmed response to the combination therapy, which was also well-tolerated[5](index=5&type=chunk) - PEAK-1, a Phase 3 study evaluating casdatifan + cabozantinib in IO-experienced ccRCC, and eVOLVE-RCC02, an AstraZeneca-sponsored Phase 1b/3 study evaluating casdatifan + volrustomig in first-line metastatic ccRCC, have both been initiated[5](index=5&type=chunk)[6](index=6&type=chunk) - As of the data cutoff (March 14, 2025), casdatifan + cabozantinib treatment showed a **46% confirmed overall response rate (ORR)** in patients with at least 12 weeks of follow-up, with tumor shrinkage observed in almost all patients[10](index=10&type=chunk) - More mature data for the casdatifan monotherapy cohort from the ARC-20 study are expected in **Fall 2025**, with more mature data for the casdatifan plus cabozantinib cohort and preliminary data from new ARC-20 cohorts anticipated in **2026**[10](index=10&type=chunk) [Domvanalimab (Fc-silent anti-TIGIT Antibody) & Zimberelimab (anti-PD-1 Antibody)](index=2&type=section&id=2.2%20Domvanalimab%20(Fc-silent%20anti-TIGIT%20antibody)%20%26%20Zimberelimab%20(anti-PD-1%20antibody)) Overall survival (OS) data from the Phase 2 EDGE-Gastric study of domvanalimab plus zimberelimab with chemotherapy in GI cancers will be presented at the **2025 ESMO Congress**, with the first Phase 3 OS data from the STAR-221 study expected in **2026** - An abstract for overall survival (OS) data from the Phase 2 EDGE-Gastric study evaluating domvanalimab + zimberelimab + chemotherapy in gastrointestinal (GI) cancers has been accepted for presentation at the **2025 European Society for Medical Oncology (ESMO) Congress** in October[5](index=5&type=chunk)[10](index=10&type=chunk) - The first Phase 3 OS data for domvanalimab + zimberelimab will come from the ongoing STAR-221 study, evaluating domvanalimab + zimberelimab + chemotherapy in PD-L1 all-comer, treatment-naive, unresectable or metastatic upper GI adenocarcinomas, with results anticipated in **2026**[10](index=10&type=chunk) [Quemliclustat (Small-Molecule CD73 Inhibitor)](index=2&type=section&id=2.3%20Quemliclustat%20(small-molecule%20CD73%20inhibitor)) Quemliclustat received US FDA orphan drug designation for pancreatic cancer, and its Phase 3 PRISM-1 trial (in combination with gemcitabine/nab-paclitaxel for first-line metastatic pancreatic ductal adenocarcinoma) is rapidly enrolling patients, with enrollment expected to complete in **Q3 2025** - The U.S. Food and Drug Administration (FDA) granted orphan drug designation to quemliclustat for the treatment of pancreatic cancer[10](index=10&type=chunk) - PRISM-1, a Phase 3 trial of quemliclustat in combination with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel in first-line metastatic pancreatic ductal adenocarcinoma, is rapidly enrolling, with enrollment expected to complete in **Q3 2025**[10](index=10&type=chunk) [Etrumadenant (Adenosine A2a/A2b Receptor Antagonist)](index=2&type=section&id=2.4%20Etrumadenant%20(adenosine%20A2a%2fA2b%20receptor%20antagonist)) Despite FDA confirmation of etrumadenant's registrational potential in third-line metastatic colorectal cancer, Arcus and Gilead decided not to pursue a Phase 3 study due to strategic priorities, and Gilead returned the etrumadenant license to Arcus in **June 2025** - Arcus and Gilead agreed not to advance a Phase 3 study for etrumadenant in third-line metastatic colorectal cancer (mCRC) at this time, despite FDA feedback confirming the program's potential for a registrational path[7](index=7&type=chunk) - In **June 2025**, Gilead returned its license rights to etrumadenant to Arcus[7](index=7&type=chunk) [Early Discovery Programs](index=2&type=section&id=2.5%20Early%20Discovery%20Programs) Arcus is conducting multiple research and preclinical programs targeting validated oncology and inflammation targets, with the next development candidate expected to be a small molecule for an inflammation target - Arcus is conducting multiple research and preclinical programs targeting validated oncology and inflammation targets[8](index=8&type=chunk) - Arcus anticipates that the next development candidate to enter the clinic will be a small molecule targeting an inflammation target[8](index=8&type=chunk) [Financial Performance](index=2&type=section&id=Financial%20Performance) [Second Quarter 2025 Financial Highlights](index=2&type=section&id=3.1%20Second%20Quarter%202025%20Financial%20Highlights) Arcus achieved significant revenue growth in Q2 2025, primarily due to a **$143 million** cumulative revenue catch-up adjustment related to etrumadenant license return, while R&D expenses increased, net loss significantly narrowed, and **$927 million** in cash, cash equivalents, and marketable securities are sufficient to support initial key clinical data readouts Key Financial Data for Q2 2025 | Metric | Q2 2025 (million USD) | Q2 2024 (million USD) | Change (million USD) | Change (%) | | :-------------------------------- | :-------------------- | :-------------------- | :------------------- | :--------- | | **Revenue** | 160 | 39 | 121 | 310.26% | | **Research and Development Expenses** | 139 | 115 | 24 | 20.87% | | **General and Administrative Expenses** | 29 | 30 | -1 | -3.33% | | **Net Income (Loss)** | 0 | (93) | 93 | -100.00% | | **Cash, Cash Equivalents, and Marketable Securities (End of Period)** | 927 | N/A (vs. Dec 31, 2024: 992) | -65 | -6.55% | - Revenue growth was primarily driven by a **$143 million** cumulative revenue catch-up adjustment related to the cessation of future etrumadenant development and Gilead's return of its license rights[15](index=15&type=chunk) - Research and development expenses increased primarily due to higher CMC costs and increased early-stage development activities (Phase 2 activities for casdatifan), partially offset by lower STAR-221 costs[15](index=15&type=chunk) - As of **June 30, 2025**, cash, cash equivalents, and marketable securities totaled **$927 million**, a decrease from **$992 million** as of December 31, 2024, but the company believes existing funds are sufficient to support initial key data readouts for domvanalimab, quemliclustat, and casdatifan (including PEAK-1)[9](index=9&type=chunk) [Consolidated Statements of Operations](index=5&type=section&id=3.2%20Consolidated%20Statements%20of%20Operations) This section presents Arcus Biosciences' consolidated statements of operations for Q2 and the first half of 2025, detailing financial data such as license and development service revenue, other collaboration revenue, R&D expenses, G&A expenses, and net income (loss) Consolidated Statements of Operations (Unaudited) | | Three Months Ended June 30, | | Six Months Ended June 30, | | :-------------------------------- | :--- | :--- | :--- | :--- | | | **2025** | **2024** | **2025** | **2024** | | **Revenue (million USD):** | | | | | | License and development service revenue | $152 | $28 | $172 | $163 | | Other collaboration revenue | 8 | 11 | 16 | 21 | | **Total Revenue** | **160** | **39** | **188** | **184** | | **Operating Expenses (million USD):** | | | | | | Research and development | 139 | 115 | 261 | 224 | | General and administrative | 29 | 30 | 57 | 62 | | Impairment of long-lived assets | — | — | — | 20 | | **Total Operating Expenses** | **168** | **145** | **318** | **306** | | **Operating Loss** | **(8)** | **(106)** | **(130)** | **(122)** | | **Non-Operating Income (Expense) (million USD):** | | | | | | Interest and other income, net | 10 | 13 | 21 | 26 | | Interest expense | (2) | — | (3) | (1) | | **Total Non-Operating Income, net** | **8** | **13** | **18** | **25** | | **Income (Loss) Before Income Taxes** | **—** | **(93)** | **(112)** | **(97)** | | Income tax expense | — | — | — | — | | **Net Income (Loss)** | **$—** | **$(93)** | **$(112)** | **$(97)** | | **Net Income (Loss) Per Share:** | | | | | | Basic | $— | $(1.02) | $(1.09) | $(1.09) | | Diluted | $— | $(1.02) | $(1.09) | $(1.09) | | **Shares Used in Net Income (Loss) Per Share Calculation (millions):** | | | | | | Basic | 106.1 | 91.1 | 102.3 | 88.6 | | Diluted | 106.5 | 91.1 | 102.3 | 88.6 | [Selected Consolidated Balance Sheet Data](index=6&type=section&id=3.3%20Selected%20Consolidated%20Balance%20Sheet%20Data) This section provides selected consolidated balance sheet data for Arcus Biosciences as of **June 30, 2025**, and **December 31, 2024**, including cash, cash equivalents, marketable securities, total assets, total liabilities, and total stockholders' equity Selected Consolidated Balance Sheet Data (Unaudited) | | June 30, 2025 (million USD) | | December 31, 2024 (1) (million USD) | | :-------------------------------- | :-------------------------- | :--- | :--------------------------------- | | Cash, cash equivalents, and marketable securities | $927 | | $992 | | Total assets | 1,075 | | 1,150 | | Total liabilities | 526 | | 665 | | Total stockholders' equity | 549 | | 485 | [Additional Company Information](index=3&type=section&id=Additional%20Company%20Information) [About Arcus Biosciences](index=3&type=section&id=4.1%20About%20Arcus%20Biosciences) Arcus Biosciences, a clinical-stage global biopharmaceutical company founded in **2015**, is dedicated to developing differentiated molecules and combination therapies for cancer, advancing multiple investigational drugs into registrational clinical trials - Arcus Biosciences is a clinical-stage global biopharmaceutical company focused on developing differentiated molecules and combination therapies for cancer patients[11](index=11&type=chunk) - The company has advanced multiple investigational drugs into registrational clinical trials, including domvanalimab, casdatifan, and quemliclustat[11](index=11&type=chunk) - Domvanalimab, quemliclustat, zimberelimab, casdatifan, etrumadenant, AB598, and AB801 are all investigational molecules, not yet approved by any regulatory authority, and their safety and efficacy have not been established[12](index=12&type=chunk) [About the Gilead Collaboration](index=3&type=section&id=4.2%20About%20the%20Gilead%20Collaboration) Arcus established a **10-year** strategic collaboration with Gilead in **May 2020**, granting Gilead time-limited exclusive options for all Arcus clinical programs, and they are co-developing zimberelimab, domvanalimab, and quemliclustat, with the collaboration extended to research targets in oncology and inflammatory diseases - Arcus established a **10-year** collaboration with Gilead in **May 2020** to strategically advance its portfolio[13](index=13&type=chunk) - Gilead obtained time-limited exclusive options to all clinical programs during the collaboration term[13](index=13&type=chunk) - Arcus and Gilead are co-developing three investigational products: zimberelimab, domvanalimab, and quemliclustat, and have expanded the collaboration to research targets in oncology and inflammatory diseases[13](index=13&type=chunk) [Forward-Looking Statements & Risks](index=3&type=section&id=4.3%20Forward-Looking%20Statements%20%26%20Risks) This press release contains forward-looking statements regarding future events or results, reflecting management's current beliefs and expectations, but subject to known and unknown risks and uncertainties that could cause actual results to differ materially from expectations - This press release contains forward-looking statements, and all statements regarding future events or results reflect management's current beliefs and expectations[14](index=14&type=chunk) - All forward-looking statements involve known and unknown risks, uncertainties, and other important factors that may cause Arcus's actual results, performance, or achievements to differ materially from those expressed or implied in the forward-looking statements[14](index=14&type=chunk)[16](index=16&type=chunk) - Risk factors include, but are not limited to: preliminary and interim data not guaranteeing similar future data; unexpected adverse events in investigational products; difficulties or delays in initiating or conducting clinical trials; challenges in managing collaboration activities; changes in the competitive landscape; and uncertainties inherent in drug product development and clinical trials[16](index=16&type=chunk) [Investor & Media Contacts](index=4&type=section&id=4.4%20Investor%20%26%20Media%20Contacts) This section provides contact information for Arcus Biosciences' investor relations and corporate affairs departments, including names, titles, and contact details - Investor inquiries: Pia Eaves, Vice President, Investor Relations & Strategy, Phone: (617) 459-2006, Email: peaves@arcusbio.com[18](index=18&type=chunk) - Media inquiries: Holli Kolkey, Vice President, Corporate Affairs, Phone: (650) 922-1269, Email: hkolkey@arcusbio.com; Maryam Bassiri, Associate Director, Corporate Communications, Phone: (510) 406-8520, Email: mbassiri@arcusbio.com[18](index=18&type=chunk)

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]