Arcus Biosciences, Inc. (NYSE:RCUS) Q1 2024 Earnings Conference Call May 8, 2024 4:30 PM ET Company Participants Pia Eaves - Vice President of Investor Relations & Strategy Terry Rosen - CEO Jennifer Jarrett - COO Bob Goeltz - CFO Dimitry Nuyten - CMO Juan Jaen - President Conference Call Participants Kaveri Pohlman - BTIG Peter Lawson - Barclays Ashiq Mubarack - Citi Jonathan Miller - Evercore ISI Jason Zemansky - Bank of America Jeff La Rosa - Leerink Partners Rosemary Li - Cantor Fitzgerald Operator Hell ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 _____________________________________ FORM 10-Q _____________________________________ (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____________to _______________ Commission File Number: 001-38419 __________________ ...

[Overview and Key Highlights](index=1&type=section&id=Overview%20and%20Key%20Highlights) Arcus Biosciences reported Q1 2024 results, highlighting its evolution into a late-stage oncology company with multiple programs and a strong financial position into 2027 - Arcus is positioning itself as a **late-stage oncology company** focusing on large patient populations in lung, gastrointestinal, and kidney cancers[3](index=3&type=chunk) - The company anticipates having its molecules in at least **5 different Phase 3 studies** by the first half of 2025[3](index=3&type=chunk) - Key near-term catalysts include **two oral presentations at the 2024 ASCO Annual Meeting** and casdatifan program data expected in the second half of 2024[6](index=6&type=chunk) - The company holds a strong financial position with **$1.1 billion in cash, cash equivalents, and marketable securities**, ensuring operational funding into 2027[6](index=6&type=chunk)[11](index=11&type=chunk) [Pipeline Update](index=1&type=section&id=Pipeline%20Update) Arcus provided updates across its clinical pipeline, including progress in Phase 3 studies for domvanalimab/zimberelimab, casdatifan, and adenosine axis programs [Domvanalimab (anti-TIGIT) plus Zimberelimab (anti-PD-1)](index=1&type=section&id=Domvanalimab%20%28anti-TIGIT%29%20plus%20Zimberelimab%20%28anti-PD-1%29) The domvanalimab and zimberelimab combination is advancing in two pivotal Phase 3 trials, with enrollment completion expected in 2024 and new data at ASCO - Updated data from the Phase 2 EDGE-Gastric trial, including **median PFS**, will be presented at the ASCO Annual Meeting in June 2024[7](index=7&type=chunk) - Enrollment for the Phase 3 STAR-221 study in first-line metastatic upper GI cancers is expected to complete by **mid-2024**[7](index=7&type=chunk) - Enrollment for the Phase 3 STAR-121 study in first-line metastatic NSCLC is expected to complete by the **second half of 2024**[7](index=7&type=chunk) [Casdatifan (HIF-2a inhibitor)](index=1&type=section&id=Casdatifan%20%28HIF-2a%20inhibitor%29) The casdatifan program for ccRCC is progressing with multiple data readouts expected over the next 18 months, including a planned Phase 3 study in H1 2025 - Data from the ARC-20 study's **100 mg daily expansion cohort** in 2L+ ccRCC, including **ORR**, are expected in the second half of 2024[7](index=7&type=chunk) - Enrollment is complete for the **50mg cohort** and initiated for the **150mg cohort** in the ARC-20 study, with data expected over the next 18 months[7](index=7&type=chunk) - Arcus plans to initiate a **Phase 3 study of casdatifan** in combination with a TKI in ccRCC in the first half of 2025[11](index=11&type=chunk) [CD-73-Adenosine Axis: Etrumadenant and Quemliclustat](index=3&type=section&id=CD-73-Adenosine%20Axis%3A%20Etrumadenant%20and%20Quemliclustat) Adenosine axis programs showed positive results, with ARC-9 data at ASCO, improved PFS/OS in MORPHEUS-PDAC, and a planned Phase 3 trial for quemliclustat by early 2025 - Data from the ARC-9 study in **third-line metastatic colorectal cancer (mCRC)** will be presented at ASCO in June[11](index=11&type=chunk) - In the MORPHEUS-PDAC study, the etrumadenant-containing regimen showed a median PFS of **8.2 months vs. 6.8 months** and a median OS of **16.5 months vs. 12.1 months** compared to chemotherapy alone[11](index=11&type=chunk) - A **Phase 3 trial of quemliclustat** combined with chemotherapy in pancreatic cancer is planned to begin by early 2025[11](index=11&type=chunk) [Early Clinical Programs](index=3&type=section&id=Early%20Clinical%20Programs) Dose escalation for AB801, a potent AXL inhibitor, is ongoing, with plans to advance into NSCLC expansion cohorts in early 2025 - Dose escalation for **AB801**, a small-molecule AXL inhibitor, is continuing[9](index=9&type=chunk) - Arcus plans to advance **AB801 into expansion cohorts for NSCLC** in early 2025[9](index=9&type=chunk) [Financial Results for First Quarter 2024](index=3&type=section&id=Financial%20Results%20for%20First%20Quarter%202024) Arcus reported Q1 2024 revenues of **$145 million**, driven by a Gilead collaboration catch-up, with operating expenses at **$161 million** and a net loss of **$4 million** Q1 2024 Financial Performance vs. Q1 2023 (in millions) | Metric | Q1 2024 | Q1 2023 | Change | | :--- | :--- | :--- | :--- | | **Total Revenues** | $145 | $25 | +$120 | | **R&D Expenses** | $109 | $81 | +$28 | | **G&A Expenses** | $32 | $30 | +$2 | | **Impairment of Long-lived Assets** | $20 | $0 | +$20 | | **Total Operating Expenses** | $161 | $111 | +$50 | | **Net Loss** | ($4) | ($80) | +$76 | - The significant increase in revenue was primarily driven by a **$107 million cumulative catch-up** related to amendments in the Gilead collaboration agreement[11](index=11&type=chunk) - The increase in R&D expenses was mainly due to higher costs for **clinical manufacturing, clinical trials, and headcount** for late-stage development programs[11](index=11&type=chunk) - A non-cash impairment charge of **$20 million** was recorded due to plans to sublease a portion of the company's facilities[11](index=11&type=chunk) Balance Sheet Highlights (in millions) | Metric | March 31, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | **Cash, cash equivalents and marketable securities** | $1,095 | $866 | | **Total Assets** | $1,293 | $1,095 | | **Total Liabilities** | $586 | $633 | | **Total Stockholders' Equity** | $707 | $462 | - The increase in cash was primarily due to the receipt of **$320 million from Gilead** for an equity investment in January 2024[11](index=11&type=chunk) [Clinical Studies Overview](index=5&type=section&id=Clinical%20Studies%20Overview) Arcus provided an overview of its ongoing and planned clinical studies across various cancer types, featuring multiple investigational molecules from Phase 1 to registrational Phase 3 trials - Arcus has multiple ongoing **registrational Phase 3 trials**, including STAR-121 and PACIFIC-8 in lung cancer, and STAR-221 in upper GI cancers[13](index=13&type=chunk) - The clinical pipeline addresses a wide range of cancers, with platform studies like **EDGE-Lung and VELOCITY-Lung** designed to evaluate various combinations efficiently[13](index=13&type=chunk) - The company has planned **Phase 3 trials for its newer assets**, including PRISM-1 for quemliclustat in pancreatic cancer and STAR-131 for domvanalimab in perioperative NSCLC[13](index=13&type=chunk) [Corporate and Collaboration Information](index=6&type=section&id=Corporate%20and%20Collaboration%20Information) Arcus Biosciences is a clinical-stage biopharmaceutical company focused on cancer therapies, with a key 10-year strategic collaboration with Gilead - Arcus has a **10-year strategic collaboration with Gilead**, initiated in May 2020, to advance its portfolio[14](index=14&type=chunk) - Arcus and Gilead are co-developing **four key assets**: zimberelimab (anti-PD-1), domvanalimab (anti-TIGIT), etrumadenant (adenosine receptor antagonist), and quemliclustat (CD73 inhibitor)[14](index=14&type=chunk) - The company's focus is on developing **first- or best-in-class medicines** against well-characterized biological targets such as TIGIT, PD-1, the adenosine axis, HIF-2a, and AXL[15](index=15&type=chunk)

Arcus Biosciences, Inc. (NYSE:RCUS) Q4 2023 Earnings Conference Call February 21, 2024 5:00 PM ET Company Participants Pia Eaves - Vice President of Investor Relations Terry Rosen - CEO Jennifer Jarrett - COO Dimitry Nuyten - CMO Bob Goeltz - CFO Juan Jaen - President Conference Call Participants Terence Flynn - Morgan Stanley Peter Lawson - Barclays Kaveri Pohlman - BTIG Jonathan Miller - Evercore ISI Yigal Nochomovitz - Citigroup Robyn Karnauskas - Truist Daina Graybosch - Leerink Partners Operator Hello ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 __________________________________________________________________________________ FORM 10-K __________________________________________________________________________________ (Mark One) x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the tr ...

[Arcus Biosciences Fourth-Quarter and Full-Year 2023 Results](index=1&type=section&id=Arcus%20Biosciences%20Fourth-Quarter%20and%20Full-Year%202023%20Results) [Corporate and Strategic Updates](index=1&type=section&id=Corporate%20and%20Strategic%20Updates) Arcus strengthened its financial position and strategic partnership with Gilead, extending its cash runway into 2027 - Gilead made an additional equity investment of **$320 million**, increasing its ownership stake in Arcus to **33%**[5](index=5&type=chunk)[6](index=6&type=chunk) - As part of the expanded collaboration, Gilead's Chief Commercial Officer, Johanna Mercier, joined the Arcus board of directors[6](index=6&type=chunk) - The company's pro forma cash position is **$1.2 billion**, providing a cash runway into 2027 to support multiple Phase 3 trials and launch preparations[3](index=3&type=chunk)[5](index=5&type=chunk)[11](index=11&type=chunk) - A new clinical trial collaboration was announced with Exelixis for STELLAR-009, a Phase 1b/2 trial evaluating casdatifan with zanzalintinib in advanced solid tumors[6](index=6&type=chunk) [Pipeline Highlights and Clinical Updates](index=1&type=section&id=Pipeline%20Highlights%20and%20Clinical%20Updates) Arcus is advancing its late-stage pipeline with six Phase 3 trials expected by early 2025 and key data readouts anticipated in 2024 - By early 2025, Arcus expects to have six ongoing Phase 3 trials for three distinct programs: domvanalimab plus zimberelimab, casdatifan (HIF-2a inhibitor), and quemliclustat (CD73 inhibitor)[3](index=3&type=chunk) - Two Phase 3 trials for the domvanalimab combination, STAR-121 (NSCLC) and STAR-221 (Upper GI), are expected to complete enrollment in 2024[3](index=3&type=chunk)[9](index=9&type=chunk) - Multiple datasets are expected in H1 2024, including EDGE-Gastric data at ASCO and two randomized datasets for etrumadenant[5](index=5&type=chunk) [Domvanalimab (anti-TIGIT) plus Zimberelimab (anti-PD-1)](index=1&type=section&id=Domvanalimab%20%28anti-TIGIT%29%20plus%20Zimberelimab%20%28anti-PD-1%29) The domvanalimab clinical program was strategically modified to focus on high unmet medical needs, including a new registrational Phase 3 study - The clinical program was strategically modified to focus on areas of high unmet medical need, with enrollment in the Phase 3 ARC-10 study (1L PD-L1-high NSCLC) discontinued to potentially accelerate the Phase 3 STAR-121 study in all-comer 1L NSCLC[6](index=6&type=chunk) - A new registrational Phase 3 study, STAR-131, is planned for perioperative NSCLC[9](index=9&type=chunk) - Updated Progression-Free Survival (PFS) and Overall Response Rate (ORR) data from the Phase 2 EDGE-Gastric trial will be presented at the ASCO Annual Meeting in June 2024[9](index=9&type=chunk) [Casdatifan (AB521, HIF-2a inhibitor)](index=2&type=section&id=Casdatifan%20%28AB521%2C%20HIF-2a%20inhibitor%29) Casdatifan shows potential for greater HIF-2a inhibition with a consistent safety profile, with a Phase 3 combination study planned for early 2025 - Pharmacokinetic (PK) and pharmacodynamic (PD) data suggest casdatifan has the potential to achieve substantially greater HIF-2a inhibition than the approved competitor, belzutifan[9](index=9&type=chunk) - The safety profile appears consistent with historical trials of belzutifan, with no dose-limiting toxicities observed to date in the ARC-20 study[9](index=9&type=chunk) - Efficacy data from the 100 mg dose-expansion cohort of the ARC-20 study are expected to be presented at a medical conference in the second half of 2024[9](index=9&type=chunk) - A Phase 3 combination study in clear cell renal cell carcinoma (ccRCC) is planned to start in early 2025[9](index=9&type=chunk) [Quemliclustat (CD73 inhibitor)](index=2&type=section&id=Quemliclustat%20%28CD73%20inhibitor%29) Quemliclustat-based regimens demonstrated improved median Overall Survival in metastatic pancreatic cancer, with a Phase 3 trial expected by early 2025 - In the ARC-8 trial for metastatic pancreatic cancer (mPDAC), quemliclustat-based regimens showed a median Overall Survival (mOS) of **15.7 months**, exceeding historical benchmarks for chemotherapy alone[9](index=9&type=chunk) - A post hoc analysis showed a **37% reduction** in the risk of death compared to a matched Synthetic Control Arm[11](index=11&type=chunk) - Initiation of a Phase 3 trial in pancreatic cancer is expected by early 2025[11](index=11&type=chunk) [Etrumadenant (A2a/A2b adenosine receptor antagonist)](index=3&type=section&id=Etrumadenant%20%28A2a%2FA2b%20adenosine%20receptor%20antagonist%29) Randomized data from two Phase 1b/2 studies for etrumadenant in mCRC and mPDAC are expected in the first half of 2024 - Data from the randomized Phase 1b/2 ARC-9 study in third-line metastatic colorectal cancer (mCRC) are expected in the first half of 2024[11](index=11&type=chunk) - Data from the Roche-operationalized MORPHEUS-PDAC randomized Phase 2 study in first-line mPDAC are also expected in the first half of 2024[11](index=11&type=chunk) [Early Clinical and Preclinical Programs](index=3&type=section&id=Early%20Clinical%20and%20Preclinical%20Programs) Arcus has initiated a Phase 1 study for AB801, an AXL inhibitor, and is conducting preclinical toxicity studies for KIT-targeting candidates - A Phase 1 study (ARC-27) of AB801, a potent and highly selective AXL inhibitor, has been initiated in patients with advanced cancer[11](index=11&type=chunk) - The company is conducting preclinical toxicity studies for multiple development candidates targeting KIT for allergic and immune-mediated diseases[11](index=11&type=chunk) [Summary of Ongoing and Announced Clinical Studies](index=4&type=section&id=Summary%20of%20Ongoing%20and%20Announced%20Clinical%20Studies) The company maintains a broad clinical pipeline with multiple ongoing and planned studies, including registrational Phase 3 trials across various cancer types - The company has a broad clinical pipeline with multiple ongoing and planned studies across various cancers, including registrational Phase 3 trials in Lung Cancer (PACIFIC-8, STAR-121, STAR-131) and Gastrointestinal Cancers (STAR-221)[13](index=13&type=chunk) [Financial Results](index=3&type=section&id=Financial%20Results) Arcus reported full-year 2023 revenues of **$117 million** and a net loss of **$307 million**, maintaining a strong cash position with a runway into 2027 [Financial Position and Liquidity](index=3&type=section&id=Financial%20Position%20and%20Liquidity) Arcus maintains a robust financial position with **$866 million** in cash as of December 31, 2023, and a pro forma cash balance of **$1.2 billion** extending its runway - Cash, cash equivalents, and marketable securities were **$866 million** as of December 31, 2023[11](index=11&type=chunk) - Pro forma cash balance is **$1.2 billion** following the January 2024 equity investment from Gilead, which is expected to fund planned operations into 2027[11](index=11&type=chunk) - The company projects a year-end 2024 cash balance of between **$870 million** and **$920 million**[11](index=11&type=chunk) [Statement of Operations Analysis (Q4 & Full-Year 2023)](index=3&type=section&id=Statement%20of%20Operations%20Analysis%20%28Q4%20%26%20Full-Year%202023%29) Full-year 2023 revenues increased to **$117 million**, while R&D expenses rose to **$340 million** due to increased late-stage development activities Consolidated Statements of Operations (in millions, except per share data) | Metric | Q4 2023 | Q4 2022 | FY 2023 | FY 2022 | | :--- | :--- | :--- | :--- | :--- | | **Total Revenues** | $31 | $34 | $117 | $112 | | **R&D Expenses** | $93 | $80 | $340 | $288 | | **G&A Expenses** | $29 | $28 | $117 | $104 | | **Loss from Operations** | ($91) | ($74) | ($340) | ($280) | | **Net Loss** | ($81) | ($67) | ($307) | ($267) | | **Net Loss Per Share** | ($1.08) | ($0.93) | ($4.15) | ($3.71) | - Full-year 2023 revenues increased to **$117 million** from **$112 million** in 2022[11](index=11&type=chunk)[20](index=20&type=chunk) - The increase in full-year R&D expenses to **$340 million** was primarily driven by higher costs to support late-stage development program activities[11](index=11&type=chunk) [Balance Sheet Highlights](index=7&type=section&id=Balance%20Sheet%20Highlights) The balance sheet reflects **$866 million** in cash, cash equivalents, and marketable securities as of December 31, 2023, with total assets at **$1,095 million** Selected Consolidated Balance Sheet Data (in millions) | Metric | Dec 31, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | **Cash, cash equivalents and marketable securities** | $866 | $1,138 | | **Total Assets** | $1,095 | $1,345 | | **Total Liabilities** | $633 | $688 | | **Total Stockholders' Equity** | $462 | $657 | [About Arcus Biosciences and Collaborations](index=5&type=section&id=About%20Arcus%20Biosciences%20and%20Collaborations) Arcus Biosciences is a clinical-stage biopharmaceutical company focused on cancer therapies, underpinned by a 10-year co-development collaboration with Gilead - Arcus is a clinical-stage biopharmaceutical company developing molecules and combination medicines for cancer, founded in 2015[15](index=15&type=chunk) - The company has a 10-year collaboration with Gilead, established in May 2020, to strategically advance its portfolio[14](index=14&type=chunk) - Arcus and Gilead are co-developing four investigational products: zimberelimab (anti-PD-1), domvanalimab (anti-TIGIT), etrumadenant (adenosine receptor antagonist), and quemliclustat (CD73 inhibitor)[14](index=14&type=chunk)

Financial Data and Key Metrics Changes - The company reported a revenue of $32 million for Q3 2023, an increase from $29 million in Q2 2023, primarily driven by collaboration with Gilead [65] - Cash at the end of September 30, 2023, was $950 million, with net cash utilization of $188 million through three quarters of 2023 [40][41] - The expected cash utilization for the full year 2023 is between $265 million and $290 million, down from previous guidance of $295 million to $325 million [40] Business Line Data and Key Metrics Changes - The company continues to execute on its pipeline, including the HIF-2-alpha and adenosine pathway programs, with upcoming data readouts expected for AB521 and QEMLI [24][26] - The EDGE-Gastric study showed a confirmed overall response rate of 59% in the overall population, with a six-month landmark progression-free survival (PFS) of 77% [12][16] Market Data and Key Metrics Changes - The market opportunity for gastric, gastroesophageal junction, and esophageal adenocarcinomas is estimated to exceed $3 billion, with approximately 25,000 patients in the U.S. alone [15] - The company is positioned to be first to market with an anti-TIGIT antibody in the first-line treatment of upper GI adenocarcinomas, which is one of the fastest-growing cancer types in the U.S. and Western Europe [15][43] Company Strategy and Development Direction - The company aims to secure its position as first-to-market and best-in-class in the anti-TIGIT space, with a focus on innovative combination therapies [57] - The ongoing Phase 3 study, STAR-221, is designed to support regulatory requirements and is enrolling well ahead of schedule, driven by enthusiasm in the TIGIT field [91] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the data supporting DOM as a potential best-in-class anti-TIGIT therapy, highlighting the differentiated safety and efficacy profile compared to competitors [43][56] - The company anticipates that the data from the EDGE-Gastric study will enhance interest and accelerate recruitment in the STAR-221 study [25][91] Other Important Information - The company has a rigorous synthetic-controlled dataset for gemobraxain, showing meaningful differentiation from combination therapy [26] - The company plans to share comprehensive data from the ARC-8 study early next year, including overall survival metrics [38] Q&A Session Summary Question: Can you comment on the design for STAR-221 regarding TAP high and low populations? - Management indicated that the trial is designed to analyze both populations, but specific details on statistical analysis plans were not disclosed [44] Question: What data will indicate additional efficacy for HIF-2-alpha? - Management suggested that the Phase 2 data in the expansion cohort will provide insights into the efficacy of AB521 compared to existing treatments [48] Question: How does the company view the competitive landscape for anti-TIGIT therapies? - Management noted a growing enthusiasm for anti-TIGIT therapies among oncology KOLs, with expectations for FDA approvals [56] Question: How does the company plan to differentiate AB521 from Merck's Belzutepin? - Management emphasized that AB521 has better pharmacokinetic properties, allowing for higher drug exposure without the limitations seen in Belzutepin [72][59] Question: What are the expectations for the upcoming data from the ARC-8 study? - Management expects to present mature overall survival data early next year, which will provide a substantial dataset for analysis [62]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 _____________________________________ FORM 10-Q _____________________________________ (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____________to _______________ Commission File Number: 001-38419 ______________ ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____________to _______________ Commission File Number: 001-38419 Arcus Biosciences, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 47-3898 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 001-38419 Arcus Biosciences, Inc. (Exact Name of Registrant as Specified in its Charter) (State or other jurisdiction of incorporation or organization) 3928 Point Eden ...