Arcus Biosciences(RCUS)

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Arcus Biosciences (RCUS) Investor Presentation - Slideshow
2020-09-18 19:24
Pipeline and Strategy - Arcus Biosciences has an advanced pipeline targeting TIGIT, Adenosine, and PD-1 pathways[7] - Domvanalimab (anti-TIGIT mAb) is rapidly advancing in randomized combinations[7] - Zimberelimab (anti-PD-1 mAb) enables portfolio combination strategies with a clear path to commercialization[7] - Arcus is uniquely positioned with intra-portfolio combinations not available to other companies[7] Financial Position and Collaboration - Arcus Biosciences has over $825 million in cash[7] - The Gilead collaboration provides resources and expertise to exploit multiple intraportfolio opportunities[7] Clinical Development and Milestones - Preliminary randomized data from ongoing trials are expected in multiple settings and combinations[7] - Interim analysis of Domvanalimab and Zimberelimab in 1L NSCLC (ARC-7) is expected in the first half of 2021[24] - Preliminary Phase 1/1b data for AB680 in 1L PDAC (ARC-8) is expected in Q1 2021[24] Clinical Activity - In late-line mCRC, Etruma + mFOLFOX-6 showed a disease control rate (DCR) of 76%[57] - In patients with 3L+ mCRC, Etruma + mFOLFOX-6 showed a DCR of 64%[57]
Arcus Biosciences(RCUS) - 2020 Q2 - Quarterly Report
2020-08-06 20:22
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, 2020 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 ...
Arcus Biosciences (RCUS) Investor Presentation - Slideshow
2020-06-23 18:12
OUR VISION: COMBINING TO CURE WITH BEST-IN-CLASS CANCER THERAPIES NYSE: RCUS JUNE 2020 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 other than statements of historical facts contained in this presentation are forward-looking statements, including statements about our vision, strategy, ...
Arcus Biosciences(RCUS) - 2020 Q1 - Quarterly Report
2020-05-05 20:20
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2020 FORM 10-Q (Mark One) OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____________to _______________ 3928 Point Eden Way Hayward, CA 94545 (Address of principal executive offices) Registrant's telephone number, including area cod ...
Arcus Biosciences(RCUS) - 2019 Q4 - Annual Report
2020-03-05 21:19
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2019 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 47-3898435 ( State or other jurisdictio ...
Arcus Biosciences(RCUS) - 2019 Q3 - Quarterly Report
2019-11-05 21:30
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 September 30, 2019 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) Registrant' ...
Arcus Biosciences (RCUS) Investor Presentation - Slideshow
2019-09-11 19:33
CREATING INNOVATIVE CANCER THERAPIES BY LEVERAGING UNDEREXPLOITED BIOLOGICAL OPPORTUNITIES September 2019 NYSE: RCUS 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 other than statements of historical facts contained in this presentation are forward-looking statements, including statemen ...
Arcus Biosciences (RCUS) Investor Presentation - Slideshow
2019-08-13 19:34
Company Overview - Arcus Biosciences is creating innovative cancer therapies by leveraging underexploited biological opportunities, with an initial focus on targets in promising pathways like the ATP-adenosine pathway[1,7] - The company has a clinical-stage pipeline with four clinical compounds, with the lead program advancing into multiple Phase 1b expansion cohorts[7] - Arcus Biosciences reported $224.4 million in cash and investments as of June 30, 2019, sufficient to fund operations into 2021[7] Pipeline and Programs - AB928, a dual adenosine receptor antagonist, is being evaluated in multiple Phase 1b expansion trials, including combinations with AB122 (anti-PD-1) in CRPC, RCC, NSCLC, CRC, and TNBC[8,37] - AB680, a small molecule CD73 inhibitor, is initiating a Phase 1 safety dose-escalation study in combination with AB122, gemcitabine, and nab-paclitaxel in first-line metastatic pancreatic cancer[8,13] - AB122, an anti-PD-1 antibody, has IND clearance to initiate a tumor-type agnostic biomarker-selected trial in advanced solid tumors in collaboration with Strata Oncology[8,13] - AB154, an anti-TIGIT antibody, is in Phase 1 safety dose-escalation, currently in combination with AB122, and is initiating an expansion study in combination with AB122 in NSCLC[8,13] AB928 Clinical Data - Phase 1 dose-escalation studies of AB928 have demonstrated an excellent safety, PK, and PK/PD profile in three combination settings[29] - Preliminary Phase 1 data shows that AB928-related Grade 3 or higher adverse events were limited, with no Grade 4 or 5 events reported across studies[34] - Based on healthy volunteer data, target inhibition of A2aR is achieved at doses between 75-150 mg QD[25] Taiho Partnership - Taiho Pharmaceutical has an option to Arcus's programs in Japan and certain other Asian territories (excluding China) over a 5-year term[9,74] - The Taiho partnership generates $35 million in guaranteed payments over 3 years, with additional opt-in payments, milestones, and tiered royalties[9,74]
Arcus Biosciences(RCUS) - 2019 Q2 - Quarterly Report
2019-08-06 20:25
[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements for Arcus Biosciences, Inc. as of June 30, 2019, and for the three and six-month periods then ended, including balance sheets, statements of operations, changes in stockholders' equity, cash flows, and accompanying notes [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2019, total assets decreased to $239.0 million from $274.9 million, primarily due to reduced short-term investments, while total liabilities increased to $42.3 million and stockholders' equity decreased to $196.6 million Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2019 | December 31, 2018 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $76,068 | $71,064 | | Short-term investments | $148,330 | $185,480 | | Total current assets | $227,733 | $258,948 | | Total assets | $238,974 | $274,925 | | **Liabilities & Stockholders' Equity** | | | | Accrued liabilities | $15,552 | $6,023 | | Total liabilities | $42,328 | $39,983 | | Total stockholders' equity | $196,646 | $234,942 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For the six months ended June 30, 2019, the company reported a net loss of $45.8 million, an increase from $26.5 million in 2018, driven by higher R&D and G&A expenses, partially offset by increased collaboration revenue Statement of Operations Summary (in thousands) | Metric | Six Months Ended June 30, 2019 | Six Months Ended June 30, 2018 | | :--- | :--- | :--- | | Collaboration and license revenue | $3,500 | $2,500 | | Research and development expenses | $40,553 | $25,352 | | General and administrative expenses | $10,879 | $6,379 | | Loss from operations | ($47,932) | ($29,231) | | Net loss | ($45,760) | ($26,488) | | Net loss per share, basic and diluted | ($1.05) | ($1.01) | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the six months ended June 30, 2019, net cash used in operating activities was $36.6 million, offset by $41.0 million from investing activities, resulting in a $5.0 million net increase in cash, ending at $76.3 million Cash Flow Summary (in thousands) | Activity | Six Months Ended June 30, 2019 | Six Months Ended June 30, 2018 | | :--- | :--- | :--- | | Net cash used in operating activities | ($36,592) | ($24,124) | | Net cash provided by (used in) investing activities | $40,952 | ($32,614) | | Net cash provided by financing activities | $644 | $128,310 | | Net increase in cash, cash equivalents and restricted cash | $5,004 | $71,572 | [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's business as a clinical-stage biopharmaceutical firm, its liquidity, adoption of ASC 606 for revenue recognition, and specifics on key collaboration agreements with Taiho, WuXi Biologics, and Strata Oncology - The company is a clinical-stage biopharmaceutical company focused on creating innovative cancer immunotherapies. As of June 30, 2019, it had **$224.4 million in cash and investments**, believed to be sufficient to fund operations for at least the next twelve months[21](index=21&type=chunk)[22](index=22&type=chunk) - Effective January 1, 2019, the company adopted revenue recognition standard ASC 606, resulting in a cumulative-effect adjustment that reduced the opening accumulated deficit by **$2.2 million**. This primarily impacted the recognition of revenue from the Taiho Agreement[33](index=33&type=chunk)[44](index=44&type=chunk) - The company has several key collaboration agreements, including an option and license agreement with Taiho, a license agreement with WuXi Biologics for an anti-PD-1 antibody (AB122), and a co-development agreement with Strata Oncology[66](index=66&type=chunk)[79](index=79&type=chunk)[81](index=81&type=chunk) - In June 2019, a **$7.5 million development milestone** was reached and recorded as R&D expense under the WuXi Biologics agreement[79](index=79&type=chunk) - In connection with the Strata agreement, Arcus issued **1,257,651 restricted shares** valued at **$15.0 million**, which are subject to vesting upon achievement of regulatory milestones. As of June 30, 2019, none were considered probable of vesting[82](index=82&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=19&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses increased operating expenses, with R&D rising 60% to $40.6 million for the first six months of 2019, driven by milestone payments and clinical trial costs, noting $224.4 million in cash and investments are expected to fund operations for at least 12 months, with future capital needs anticipated Comparison of Results of Operations (in thousands) | Metric | Six Months Ended June 30, 2019 | Six Months Ended June 30, 2018 | Change (%) | | :--- | :--- | :--- | :--- | | Collaboration and license revenue | $3,500 | $2,500 | 40% | | Research and development | $40,553 | $25,352 | 60% | | General and administrative | $10,879 | $6,379 | 71% | | Net loss | ($45,760) | ($26,488) | 73% | - The increase in R&D expenses for the first six months of 2019 was primarily due to a **$7.5 million milestone payment** under the WuXi Agreement, a **$7.3 million increase in clinical costs** for its four clinical-stage programs, and a **$2.3 million increase in employee compensation**[114](index=114&type=chunk) - As of June 30, 2019, the company had **$224.4 million in cash and investments**, which management believes is sufficient to fund operations for at least the next 12 months[119](index=119&type=chunk)[120](index=120&type=chunk) - The company will require substantial additional capital to develop its product candidates and fund future operations, with needs dependent on factors like clinical trial costs, manufacturing, and potential milestone payments[121](index=121&type=chunk)[124](index=124&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=25&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company states its market risks, primarily from interest and exchange rates, have not materially changed from its 2018 Annual Report, with no significant impact from inflation, interest rate changes, or exchange rate fluctuations - The company's market risks related to interest rates and exchange rates have **not materially changed** since the last annual report[136](index=136&type=chunk) [Controls and Procedures](index=25&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, concluded the company's disclosure controls and procedures were effective as of June 30, 2019, with no material changes in internal control over financial reporting during the quarter - The CEO and CFO concluded that the company's disclosure controls and procedures were **effective** as of the end of the period covered by the report[139](index=139&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that have materially affected, or are reasonably likely to materially affect, internal controls[140](index=140&type=chunk) [PART II. OTHER INFORMATION](index=26&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=26&type=section&id=Item%201.%20Legal%20Proceedings) The company reports it is not currently a party to any material legal proceedings but acknowledges potential future involvement in ordinary course of business matters - Arcus Biosciences is **not currently involved in any material legal proceedings**[143](index=143&type=chunk) [Risk Factors](index=26&type=section&id=Item%201A.%20Risk%20Factors) This section outlines numerous risks, including limited operating history, history of net losses, need for substantial additional funding, high development risks for early-stage product candidates, reliance on third parties, intellectual property protection challenges, intense competition, and complex regulatory and legal environments - **Financial Risks:** The company is an early-stage entity with a history of net losses (**$45.8 million** for the six months ended June 30, 2019) and will require substantial additional funding to continue operations[145](index=145&type=chunk)[147](index=147&type=chunk) - **Development Risks:** All product candidates are in early development stages. The success of its intra-portfolio combination strategy (e.g., AB928 with AB122) is **unproven** and faces **high risk of failure**[154](index=154&type=chunk)[161](index=161&type=chunk)[162](index=162&type=chunk) - **Third-Party Reliance:** The company relies on third parties for manufacturing (e.g., WuXi Biologics for AB122) and conducting clinical trials, which introduces risks related to quality, supply interruptions, and regulatory compliance (cGMP, GCP)[186](index=186&type=chunk)[189](index=189&type=chunk) - **Competition Risk:** The company faces substantial competition from large pharmaceutical companies like Bristol-Myers Squibb, Merck, and AstraZeneca, which have approved products and greater resources, particularly in the anti-PD-1 space[259](index=259&type=chunk)[260](index=260&type=chunk)[261](index=261&type=chunk) - **Intellectual Property Risk:** The company's success depends on obtaining and maintaining patent protection. It faces risks of patent challenges, infringement lawsuits from third parties (e.g., potential issues with BMS patents on anti-PD-1 antibodies), and the difficulty of protecting trade secrets[224](index=224&type=chunk)[233](index=233&type=chunk)[234](index=234&type=chunk) - **Regulatory and Legal Risks:** The business is subject to extensive regulation by the FDA and foreign agencies, potential product liability lawsuits, and complex healthcare laws (e.g., Anti-Kickback Statute, Affordable Care Act), which are subject to change and strict enforcement[272](index=272&type=chunk)[275](index=275&type=chunk)[296](index=296&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=70&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) On April 30, 2019, the company issued 1,257,651 restricted shares to Strata Oncology, Inc. as part of a collaboration agreement, and confirms no material change in the planned use of IPO proceeds - Issued **1,257,651 restricted shares** to Strata Oncology, Inc. on April 30, 2019, in a private placement as part of a collaboration agreement[323](index=323&type=chunk) - There has been **no material change** in the planned use of proceeds from the company's Initial Public Offering (IPO)[324](index=324&type=chunk) [Defaults Upon Senior Securities](index=70&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) None reported [Mine Safety Disclosures](index=70&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) None reported [Other Information](index=70&type=section&id=Item%205.%20Other%20Information) None reported [Exhibits](index=71&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including corporate documents, an offer letter, an amendment to the WuXi Biologics license agreement, and CEO/CFO certifications
Arcus Biosciences(RCUS) - 2019 Q1 - Quarterly Report
2019-05-02 20:08
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, 2019 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 47-389 ...