Clinical Development - The company is focused on developing best-in-class therapies, with its most advanced molecule, an anti-TIGIT antibody, currently in multiple Phase 3 registrational studies targeting lung and gastrointestinal cancers[86]. - The company has a clinical pipeline that includes investigational products targeting unique mechanisms such as TIGIT, PD-1, and CD73, with significant collaborations with Gilead and Taiho[87]. - In October 2024, the company reported a 34% objective response rate for casdatifan in a Phase 1/1b study for metastatic clear cell renal carcinoma, with a disease control rate of 81%[91]. - The company announced a 36% reduction in risk of death for the combination of domvanalimab and zimberelimab in a study for PD-L1 high non-small cell lung cancer[92]. - The company initiated the Phase 3 PRISM-1 trial for quemliclustat in pancreatic cancer, which is expected to advance its clinical development[93]. - The company entered into a clinical collaboration with AstraZeneca to evaluate casdatifan in combination with volrustomig for clear cell renal carcinoma[90]. - Taiho exercised its option for quemliclustat, leading to operationalization of the Phase 3 PRISM-1 study in Japan and potential milestone payments for the company[90]. Financial Performance - Total revenues for the three months ended September 30, 2024, increased by 50% to $48 million, driven by a $15 million license revenue from Taiho[100]. - License and development services revenue rose by 86% to $41 million for the three months ended September 30, 2024, and by 252% to $204 million for the nine months ended September 30, 2024[100][101]. - Non-operating income increased by 18% to $13 million for the three months ended September 30, 2024, attributed to higher investment yields[100][105]. - The company recognized a cumulative catch-up to revenue of $107 million due to the updated transaction price and measure of progress for partially satisfied performance obligations related to the Third Gilead Collaboration Agreement Amendment[115]. - A hypothetical 10% change in the updated standalone selling prices related to the Third Gilead Collaboration Agreement Amendment could have altered the cumulative catch-up to revenue recognized during the current year by as much as $3 million[115]. Expenses and Cash Flow - The company has not generated any revenue from product sales and does not expect to do so in the foreseeable future, relying instead on collaboration and license arrangements[94]. - Research and development expenses are expected to increase significantly as the company advances joint development programs with Gilead and expands its clinical-stage portfolio[98]. - General and administrative expenses are anticipated to rise due to staff expansion and increased infrastructure needs to support growing R&D activities[99]. - Research and development expenses increased by 50% to $123 million for the three months ended September 30, 2024, primarily due to higher costs for late-stage program activities[104][105]. - Total operating expenses for the three months ended September 30, 2024, increased by 37% to $153 million, with a notable rise in R&D costs[100]. - Net cash used in operating activities was $70 million for the nine months ended September 30, 2024, a significant improvement from $218 million in the prior year[110]. - The company received $320 million from Gilead in January 2024, which contributed to increased liquidity and investment capacity[107]. - The impairment charge for long-lived assets was $20 million for the nine months ended September 30, 2024, due to the evaluation of office space expected to be subleased[105]. - The company has sufficient cash and marketable securities to fund operations into mid-2027[106]. Shareholder Information - Gilead held approximately 32.9% of the company's outstanding common stock as of September 30, 2024, following recent stock purchases[107]. Market Risks - The company’s market risks, including potential losses from changes in interest rates and foreign currency exchange rates, have not changed materially from those discussed in the Annual Report on Form 10-K filed on February 21, 2024[117].

Financial Performance - Arcus reported revenues of $48 million for Q3 2024, up from $32 million in Q3 2023, driven by $41 million in license and development services revenue[12]. - Arcus Biosciences reported total revenues of $48 million for the three months ended September 30, 2024, compared to $32 million for the same period in 2023, representing a 50% increase[23]. - License and development services revenue was $41 million for the three months ended September 30, 2024, up from $22 million in the same period last year, indicating an 86% growth[23]. - The net loss for the three months ended September 30, 2024, was $92 million, compared to a net loss of $71 million for the same period in 2023[23]. Cash and Assets - The company has $1.1 billion in cash, cash equivalents, and marketable securities as of September 30, 2024, sufficient to fund operations into mid-2027[11]. - Arcus expects its cash, cash equivalents, and marketable securities of $1.091 billion as of September 30, 2024, to fund operations into mid-2027[21]. - Total assets increased to $1.252 billion as of September 30, 2024, compared to $1.095 billion at the end of 2023[24]. - Total stockholders' equity rose to $565 million as of September 30, 2024, up from $462 million at the end of 2023[24]. - The company recognized a $100 million option continuation payment from Gilead in July 2024, contributing to the increase in cash reserves[12]. Research and Development - Research and Development expenses rose to $123 million in Q3 2024, compared to $82 million in Q3 2023, primarily due to higher clinical trial costs[12]. - Research and development expenses increased to $123 million for the three months ended September 30, 2024, compared to $82 million for the same period in 2023, reflecting a 50% rise[23]. - Arcus is advancing its Phase 3 study for casdatifan (PEAK-1) in post-immuno-oncology patients, expected to initiate in the first half of 2025[5]. - Arcus announced a clinical collaboration with AstraZeneca to evaluate casdatifan in combination with volrustomig in IO-naive patients with ccRCC[3]. - Arcus plans to present updated data from multiple expansion cohorts of ARC-20 in the first quarter of 2025[6]. Clinical Outcomes - The objective response rate for casdatifan in the 100mg daily cohort of the ARC-20 study was 34%, with a low primary progression rate of 19%[4]. - Domvanalimab plus zimberelimab reduced the risk of death by 36% in first-line metastatic non-small cell lung cancer compared to zimberelimab alone[7]. - The median overall survival for domvanalimab plus zimberelimab has not been reached, while zimberelimab alone reached a median overall survival of 2 years[7]. Collaborations - Arcus is co-developing four investigational products with Gilead, including zimberelimab and domvanalimab, as part of a collaboration established in May 2020[18]. - The collaboration with Gilead was expanded in November 2021 and May 2023 to include additional oncology and inflammatory disease targets[18]. - Arcus has not received approval from any regulatory authority for its investigational products, and their safety and efficacy have not been established[20].

Company Overview - Arcus Biosciences, Inc. (NYSE: RCUS) focuses on developing immunotherapies targeting lung, gastrointestinal (GI), kidney, pancreatic, and colorectal cancers [1] - The company specializes in discovering and designing small molecules and antibodies that are optimized for combination therapies [1] - Arcus aims for accelerated development by leveraging a deep understanding of cancer mechanisms and forming strategic collaborations [1] Research and Development Strategy - The company emphasizes the importance of understanding cancer mechanisms to enhance the effectiveness of its therapies [1] - Strategic collaborations are a key component of Arcus's approach to expedite the development of its immunotherapy products [1]

Matteo Colombo/DigitalVision via Getty Images Topline Summary and Update Arcus Biosciences, Inc. (NYSE:RCUS) is a cancer-focused biotech I've covered a few times with relative optimism, and as an investment thesis, it has yet to pay off. However, with an important trial update at this year's ASCO Annual Meeting and a number of important upcoming catalysts, I'm inclined to remain upbeat about the company's outlook, despite the more recent setbacks faced by the TIGIT story. Let's take another look. Pipeline U ...

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. CORPORATE PRESENTATION August 8, 2024 Forward-looking Statements/Safe Harbor This presentation contains forward-looking statements about Arcus Biosciences, Inc. ("we," "Arcus" or the "Company") made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements regarding events or results to occur in the ...

Arcus Biosciences, Inc. (RCUS) came out with a quarterly loss of $1.02 per share in line with the Zacks Consensus Estimate. This compares to loss of $1.04 per share a year ago. These figures are adjusted for nonrecurring items. A quarter ago, it was expected that this company would post a loss of $0.97 per share when it actually produced a loss of $0.05, delivering a surprise of 94.85%. Over the last four quarters, the company has surpassed consensus EPS estimates three times. Arcus Biosciences, which belon ...

Implied volatility shows how much movement the market is expecting in the future. Options with high levels of implied volatility suggest that investors in the underlying stocks are expecting a big move in one direction or the other. It could also mean there is an event coming up soon that may cause a big rally or a huge sell-off. However, implied volatility is only one piece of the puzzle when putting together an options trading strategy. Given the way analysts feel about Arcus Biosciences right now, this h ...

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)